Regulatory Affairs Associate Resume Samples

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MT
M Tremblay
Makenna
Tremblay
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Chicago
IL
+1 (555) 687 0422
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IL
Phone
p +1 (555) 687 0422
Experience Experience
Houston, TX
Regulatory Affairs Associate
Houston, TX
Leuschke LLC
Houston, TX
Regulatory Affairs Associate
  • Providing Regulatory advice and support to internal and external customers from development through full life cycle management
  • Be willing to work with a Lean team and wear multiple hats to create smart strategies for regulatory submissions and an expanding Quality Management System
  • Provide regulatory leadership for new product development and change management activities
  • Coordinate/manage the review and approval process of senior management of the company for all regulatory submissions on company development compounds
  • Participates in activities to create and improve regulatory processes and systems
  • Establishes confidence in one’s regulatory abilities and develops long-term trusting relationships
  • Provide technical customer assistance
Phoenix, AZ
Senior Regulatory Affairs Associate
Phoenix, AZ
Lubowitz-Hessel
Phoenix, AZ
Senior Regulatory Affairs Associate
  • Prepare and execute regulatory strategies/plans. Provide ongoing support to product development teams for regulatory issues/questions
  • At the direction of the Manager, Regulatory Affairs, perform training on regulatory-related matters with Acclarent personnel
  • Assisting with the development and implementation of global GSK regulatory strategy
  • Assist with label development and review for compliance before release
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
  • Assist in SOP development and review
  • Provide project management oversight (tracking, planning, timelines) for regulatory (MOH) submissions
present
Philadelphia, PA
Regulatory Affairs Associate Director
Philadelphia, PA
Yost and Sons
present
Philadelphia, PA
Regulatory Affairs Associate Director
present
  • Directs and oversees the work of regulatory professionals, including training, mentoring, and ensuring professional development
  • Serves as a departmental knowledge resource, counseling, advising, and training on all/most facets of departmental function
  • Responsibility for establishing prioritization of departmental tasks and projects
  • Provides guidance to members of the ARC regarding the current regulatory environment and regulatory considerations that may impact business activities
  • Establishes and/or approves Zimmer Biomet RA policy and procedures and ensures compliance with them; may include training RA team or cross-functional groups
  • Regulatory strategies, policies, cross-functional projects, and interdepartmental decision-making
  • Act as liaison for temporary/contract workers
Education Education
Bachelor’s Degree in Pharmacy
Bachelor’s Degree in Pharmacy
Michigan State University
Bachelor’s Degree in Pharmacy
Skills Skills
  • Strong software troubleshooting skills highly desirable
  • Pays close attention to detail, strong organizational skills, and ability to prioritize multiple projects
  • Strong verbal and written communication skills, Good computer skills with knowledge of Microsoft Office
  • Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects
  • Strong attention to detail
  • Experience in the medical device or related industry with demonstrated knowledge of scientific principles (e.g., R&D, Quality)
  • Good computer skills with knowledge of Microsoft Office
  • Demonstrates advanced knowledge and understanding of applicable regulations
  • Ability to enable and drive change
  • Displays good interpersonal skills and ability to deal effectively with a variety of personnel
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15 Regulatory Affairs Associate resume templates

1

Regulatory Affairs Associate Resume Examples & Samples

  • 2+ years of professional experience in Pharmaceutical industry
  • Exceptional writing and IT skills required
  • Advanced proficiency in Microsoft Word, PowerPoint, Outlook and Excel
  • 2+ years of experience in Regulatory Affairs
  • Master's Degree in Regulatory Affairs
2

Senior Regulatory Affairs Associate Resume Examples & Samples

  • Bachelor’s Degree, preferably in a Life Science field
  • Minimum of 3-5 years
  • Pharmaceutical industry, laboratory, or clinical research experience
  • Intermediate proficiency in Microsoft Office Suite
  • Commitment to quality of all assigned projects
  • Excellent written and oral skills
  • Commitment to the regulatory affairs profession
  • Regulatory affairs experience
3

Clinical Regulatory Affairs Associate Resume Examples & Samples

  • Develop and oversee all promotional and contest initiatives of station
  • Directly supervise employees in the Promotions Department including but not limited to hiring, training, disciplining and appraising performance of employees
  • Write, create and produce on-air promotional
  • Plan and develop station promotions
  • Supervise stations contests including originating or adapting ideas, arranging prizes and listener events
  • Maintain accurate records of contestants, and ensure contests are conducted in accordance with FCC regulations and law
  • Represent station at community events and promotions
  • Coordinate activities of other departments involved in production of promotions and remotes
  • Maintain stations prize closet, inventory of station premiums and inventory and control of station banners
  • Prepare affidavits for clients attesting to the promotional announcements aired for a particular campaign
  • Coordinate all prizes and winners and make sure prizes are available for front desk distribution
  • Handle all release forms to insure 1099’s are in order for distribution
  • College degree in Communications or Marketing preferred but not required
  • Minimum two years’ experience in broadcast marketing, public relations or related field
  • Knowledge of all FCC rules and regulations related to broadcast marketing
  • Ability to work under tight deadlines
  • Ability to work well with others
  • Ability to handle stress and related pressures
  • Valid driver’s license and dependable transportation
  • Ability to frequently lift and/or move in excess of 50 pounds
4

Regulatory Affairs Associate Resume Examples & Samples

  • 2-3 years industry experience in the pharmaceutical or biotechnology industry
  • Proven ability to manage critical projects with a minimum of supervision
  • Prior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines
  • Prior experience in a product development role
  • Proficient with computer and standard software programs
  • Strong interpersonal and communication (written and verbal) skills
  • Demonstrated good judgment
  • Capable of working with an interdisciplinary team
5

Senior Regulatory Affairs Associate Resume Examples & Samples

  • BA/BS in a scientific, healthcare or related field or equivalent experience. Advanced degree preferred, but not required
  • At least 1-3 years of relevant regulatory affairs and drug development experience or equivalent biopharmaceutical experience with a strong emphasis on regulatory affairs and drug development
  • Knowledge of US FDA regulations and guidelines on drug development and the approval process for NDA/BLAs as well as postmarketing supplements
  • Strong written/verbal communication skills
  • Well organized with attention to detail
6

Regulatory Affairs Associate Resume Examples & Samples

  • 2 to 3 years of experience
  • Regulatory Affairs or related coursework
  • Proofreading abilities
  • Working knowledge and experience with 21 CFR, US FDA guidance, ICH guidelines
  • Strong computer skills in order to learn new programs as quickly as possible
  • Experience in MS Word, Excel, Outlook and Adobe Acrobat
  • Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment
  • Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects
  • Excellent written and verbal communication skills and interpersonal skills
  • Ability to communicate effectively and collaboratively as part of a team in a respectful manner
  • Ability to interface with professionals domestically and abroad
  • Ability to work independently, self-starter
  • Good problem solving skills and analytical ability
7

Regulatory Affairs Associate Resume Examples & Samples

  • Preparation and submission of regulatory documents for new marketing authorisation applications, variations and renewals
  • Regulatory manufacturing compliance activities including review of change controls, maintenance of compliance documentation and notices of regulatory approval
  • Review and approval of product artworks
  • Review and approval of raw material / finished product / packaging material specifications and other controlled documents for compliance with the Marketing Authorisations
  • Support to the Regulatory Affairs department, including archiving of regulatory dossiers and correspondence
  • Maintenance of tracking databases in relation to the status of ongoing regulatory activities
  • Extensive experience working in a pharmaceutical regulated environment
  • Over 2 years' experience in a similar role with a major focus in Regulatory affairs
8

Regulatory Affairs Associate Resume Examples & Samples

  • Maintain an ellent understanding of global medical device
  • Communicates country/region specific regulatory requirements to the regulatory specialists/ managers
  • Advise all functional units across engineering, marketing, operations and quality of the requirements in each target market
  • Ensure the outputs from the individual functional units meet the applicable regulatory requirements
  • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as required
  • Maintain registration information including license numbers, expiration dates and more, including re-registrations
  • Communication of the clinical requirements for regulatory registrations for the product and working as part of a cross functional team to ensure that they are adequately addressed
  • Co-ordinate multiple projects at one time and provides regular reports to regulatory management and others as required
  • Prepare and submit regulatory documents for new marketing authorisation applications, variations and renewals
  • Review and approval of product artworks, raw material / finished product / packaging material specifications and other controlled documents for compliance with the Marketing Authorisations
  • Extensive experience working in a medical device regulated environment
  • Third level Qualification in Science/Engineering
  • 5 years experience in a regulated industry in a similar role
  • Good communication and inter-personal skills
  • Proven problem-solving skills and self-motivated
9

Commercial Regulatory Affairs Associate Resume Examples & Samples

  • Bachelor’s Degree with pharmaceutical industry work experience
  • Process orientation and management skills
  • Excellent project management skills including meeting facilitation, organization and time management
  • Microsoft Office, including Excel, Word and PowerPoint proficiency
10

Regulatory Affairs Associate Resume Examples & Samples

  • Lead risk management and design control process from a regulatory perspective
  • Ensure company operations are fully compliant with product licences and are updated accordance with the relevant guideline and directives
  • Compilation of global regulatory submissions
  • Co-ordination of the licenses for controlled substance and others documentation
  • Conduct internal and external quality audits
  • Keep up to date with industry related regulatory legislation and trends
11

Senior Regulatory Affairs Associate Resume Examples & Samples

  • 6+ years of relevant work experience; 6+ months of prior experience managing interns and/or external consultants
  • Bachelor's Degree in a Natural Sciences-related field
  • Solid knowledge of Regulatory Agency organizations
  • Solid negotiating and influencing skills
  • Experience with FDA registered products such as medical devices and OTC drugs
  • Prior experience working in the Pharmaceutical, CPG, and/or Healthcare industry
  • Bilingual (English and Spanish)
12

Regulatory Affairs Associate Resume Examples & Samples

  • Bachelor's Degree in chemistry, biology or other related scientific discipline
  • 2-3+ years in the pharmaceutical industry, with at least 1-2 years of Regulatory experience supporting US FDA pharmaceutical products
  • Proficiency in eCTD Publishing Software
  • Good understanding of regulatory requirements for ANDAs and 505b(2) applications
  • Good knowledge of FDA guidelines, ICH and related guidelines
  • Demonstrates a basic understanding of pharmaceutical drug development
  • Proficiency in Microsoft office and XML programs
  • Previous R&D (analytical or formulation) experience
  • 505b(2) experience
13

Regulatory Affairs Associate Resume Examples & Samples

  • Provide regulatory leadership for new product development and change management activities
  • Compile, prepare regulatory documents (summary technical documents, essential requirements checklists, 510(k)’s, Biologic License Applications, European Union-EU design dossiers)
  • Develop product registration strategies that enable accelerated product development through knowledge of Food and Drug Administration (FDA) regulations, EU Directives, International Organization for Standardization (ISO) standards, etc
  • Provide support on special regulatory assignments relating to the development of internal procedures, training, interpretation of existing and new international regulations
  • Plan and execute global product registrations on time
  • Review product design, label, manufacturing location or other changes for impact on product registrations
  • Review product labeling and claims for compliance to applicable regulations
  • Assure regulatory compliance in all activities
  • Bachelor’s degree or higher in a Science or Engineering discipline from an accredited institution
  • Minimum of three (3) years of experience Regulatory Affairs related to combination products, biological products and/or medical devices
  • Bachelor’s degree or higher in Pharmacy, Engineering, Biological Sciences, Chemistry or related discipline from an accredited institution
  • Minimum of five (5) years of regulatory experience interacting with FDA and/or other regulatory bodies worldwide
  • Demonstrated technical/scientific skills, excellent technical communication skills (oral and written), effective interpersonal and organizational skills and the ability to meet deadlines
  • Demonstrated history of accomplishments and contributions to business in previous assignment in support of regulated products
  • Proven project leadership and excellent communication skills
  • Knowledge of or experience with tissue and/or biologic regulations
  • Regulatory Affairs Professionals Society (RAPS) Regulatory Affairs Certification (RAC) certification
  • Bilingual (English and Spanish or Chinese-Mandarin) a plus
14

Regulatory Affairs Associate Resume Examples & Samples

  • The Regulatory Affairs Associate will be a member of the local regulatory affairs department within Johnson & Johnson Medical, with responsibility for regulatory aspects of the assigned product portfolio/s
  • Preparation of submissions to the local health authority for new products and variations to existing products in line with Marketing launch plans, with guidance from senior regulatory colleagues as necessary
  • Build constructive relationships with the local health authority by compiling and submitting high quality submissions and providing prompt responses to questions
  • Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio
  • Contribute to continuous review and improvement of processes within the Country Regulatory Affairs (PA) department to ensure consistent, efficient and effective practices across the team
  • Participate in discussion groups for the industry association, as required
  • Contribute to PA Team meetings to learn from colleagues, share experiences and best practice
  • Assist PA colleagues in supporting other product portfolios or PA activities, as required
  • Establish meetings with Marketing colleagues to share information about new products, line extensions and changes to currently approved products and review timelines for product approvals
15

Regulatory Affairs Associate Resume Examples & Samples

  • Blue Sheet inquiries: enter data into Firm’s system, research options, approve all inquiries via Electronic Blue Sheets Management System, maintain strict timeline for entry and approval of Blue Sheet inquiries, print and maintain daily Blue Sheet entry records for audit purposes and adhere to document retention schedule per industry guidelines
  • Assist with Self-Regulatory Organizations (SRO) examinations of Scottrade
  • Assist with regulatory inquiries
  • Create written reports to be reviewed by the Regulatory Supervisor
  • Knowledge of financial markets and brokerage industry
  • Excellent research/problem solving skills
  • Quick and accurate typing
  • Business writing skills
  • Ability to analyze documents
  • Ability to manage time and prioritize tasks
  • Intermediate level proficiency with Microsoft Word, PowerPoint, Excel, and Outlook
  • Foster company success through a professional appearance, being courteous to regulators, customers and all Scottrade associates and by having a positive attitude
  • High school diploma or equivalent combination of education and experience required. Bachelor’s Degree in Business or related field preferred
  • 2+ years brokerage experience preferred. Online brokerage experience preferred
  • Operational experience at a securities firm preferred
16

International Regulatory Affairs Associate Resume Examples & Samples

  • Provide international regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents.)
  • Provide general support for international regulatory team and projects, as needed
  • Coordinate the generation and maintenance of product International Dossiers and all related supporting documentation for international product registrations
  • Supply International Dossiers and other related information (e.g. Certificate to Foreign Government, etc.) to Bard IBCs; help coordinate and respond to inquiries from Bard IBCs through use of various internal systems, in order to facilitate new product registration, design change notifications, license renewals, and international marketing tendering and reimbursement processes
  • Research and respond to regulatory questions received from other division functions and outside sources (i.e., distributors, customs issues, etc.)
  • Coordination, review, and submission of product labeling for marketing outside the United States
  • Manage key internal systems, databases, and records
  • Understand the company’s products, surgical techniques and the use of implants and other devices
  • Bachelor’s degree required, with an understanding of healthcare industry
  • Associate: Minimum 0-3 years of international regulatory experience with medical device registrations (including CE Design Dossiers, Technical Files, and International Dossiers) and knowledge of compliance to international harmonized standards and international regulations (such as US FDA, MDD, Japan, Canada, Australia, Latin America and Asia Pacific)
  • Specialist: Minimum 3 years of international regulatory experience with medical device registrations (including CE Design Dossiers, Technical Files, and International Dossiers) and knowledge of compliance to international harmonized standards and international regulations (such as US FDA, MDD, Japan, Canada, Australia, Latin America and Asia Pacific)
  • Experience working with international businesses or cultures
  • Good oral and written communication skills – ability to work on cross-functional teams
  • Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience
  • Self-motivated by working independently and having the ability to take ownership of his/her responsibilities, the capability to work under time pressure, and to organize diverse projects in a timely manner
  • Ability to interact proactively and provide counsel and expertise to internal and external customers
  • Working knowledge of electronic documentation and information systems
  • Ability to travel approximately 10% of time
  • Professional certification preferred
  • Determination of level will be based upon years of experience & demonstrated knowledge/skills
17

Senior Regulatory Affairs Associate Resume Examples & Samples

  • A Bachelor's Degree in Science or Engineering and any additional qualifications such as a PhD or Masters in a related field would be highly regarded
  • Extremely strong ethical values working in a manner that aligns with the J&J Credo
  • Demonstrated ability to lead from the front, connect with key internal and external stakeholders, ability to shape outcomes and deliver results
  • Previous people management experience would be highly advantageous
18

Regulatory Affairs Associate Resume Examples & Samples

  • 2-3 years experience with Batch realse process – Must
  • BA in nutrition and similar OR IL Pharmacist + QP - Advantage
  • Regulatory Experience from Nutrition Importer company – Advetage
  • Understanding Quality System, and Quality Assurance
  • Strong computer skills – Excel, Word Good knowledge of local food regulations and EU directive
  • Team-player, able to working effectively with others to accomplish organizational goals
  • Able to build relationships and gain trust
  • High-level of accuracy
19

Regulatory Affairs Associate Resume Examples & Samples

  • Prepare regulatory submissions to FDA and other agencies, with direction from the Senior Director, Regulatory Affairs
  • Coordinate/manage the review and approval process of senior management of the company for all regulatory submissions on company development compounds
  • Electronically archive and catalog all submissions to and communications with regulatory agencies
  • Maintain Avid entries in clinical trial registries including clinicaltrials.gov
  • Provide administrative support to projects of other departments in the company, such as Quality Assurance, Chemical Development and Manufacturing, and Operations/contract management, as required
  • Associate’s or Bachelor’s degree in a relevant discipline preferred
  • Strong working knowledge of Microsoft Office software, especially Excel or database
  • Demonstrated excellent communication skills
  • Good interpersonal skills and desire to work in a team environment
  • Enjoys a fast-paced and hard-working environment
20

Regulatory Affairs Associate Resume Examples & Samples

  • 3+ years experience in regulatory affairs, preferably in a regulatory operations group that prepares eCTD-compliant electronic submissions
  • Knowledge of IT systems and electronic submission requirements and processes
  • Possess very strong PC computer skills
  • Strong conceptual and analytical thinking skills
  • Able to take a project from start to finish while working in a constantly changing environment
  • Positive attitude and ability to establish and maintain positive working relationships
  • Comfortable in a fast-paced fast small company environment with minimal direction and adjust workload based upon changing priorities
  • Strong multi-tasking capabilities
21

Regulatory Affairs Associate Resume Examples & Samples

  • Participate in project team meetings
  • Manage timelines
  • Prepare/QC format documents to ensure Submission Ready
  • Perform bookmarking/hypertext linking of Documents
  • Perform pre/post publishing QC
  • Coordinate, compile, publish documents to support all submissions, including literature search and references
  • Maintain Submission Log (serial numbers)
  • Provide reminder notification letters to contributors for annual and DSUR reporting requirements
  • Partner with CRO/Vendor in the compilation and build of submissions
  • Maintain submission tracking spreadsheet for all components
  • Post completed submissions into File-hold and archiving repository
  • Participate in study closeout of TMF
  • Assist in the upkeep and maintenance of document repository and filing
  • Participate in the developing of working practice/job aids/SOP
  • Thorough understanding of CFR compliance, eCTD and submission compilation Requirements (FDA, Health Canada & EMA, including post-approval commitments)
  • Assisted or directly involved in the publishing and filing of IND/CTA/NDA/MAA
  • Knowledge of SPL and eCTD compilation
  • Ability to work as a team member and independently when required
  • Ability to Multi-task, and work in a diverse and complex environment
  • Highly computer literate
22

Bilingual Regulatory Affairs Associate Manager Resume Examples & Samples

  • Responsibility for the management of product registration activities with Merial team and third part
  • Responsibility for the management of Pharmacovigilance program (capas, training for Merial emploees in CAMCAR, report to regional and global teams), in accordance with corporate policies of Regulatory Affairs and Pharmacovigilance and according to the particularities and legislation required by country
  • Manage the activities of Regulatory Affairs in order to obtain and keep licenses, renewal and changes in registers of products; action plan with business, monitoring the implementation of this plan
  • Responsibility for the RA risk assessment process to support LCM activities in compliance with the current legislation and policies and in agreement with business and R&D teams
  • To answer the demands of regulatory authorities, as well processes and activities of the department in accordance with current policies and legislation
  • Management of information and regulatory dossiers in order to ensure confidentiality, information protection and agility to provide information
  • To identify and to anticipate developments and changes in the regulatory affairs policies or in agencies organization (Regulatory Intelligence)
  • Organize and update status for the registration process
  • Develop and maintain proactive relations with the authorities responsible for regulatory affairs in the CAMCAR region as well as steakholders and influencers
  • Represent Merial in local Committees and local Union
  • Implement and monitoring commercial quality package and strategy as AQO in CAMCAR region according regional /global alignmet
  • Veterinary DVM
  • Regulatory Affairs, pharmaceutical Industry
  • Relationship with regulatory authorities, management of processes
  • Fluency in English and Spanish is mandatory
  • Setting team structure focused on services to business
  • Establish culture of PV, AQO and implement programs in Merial CAMCAR
  • Collaborative performance of BO, RA strategy
  • Maintain and intensify constructive political relationship with agencies and union
23

QA Regulatory Affairs Associate Resume Examples & Samples

  • Interacts closely with Quality Systems, Quality Assurance, Regulatory Affairs and other groups to provide guidance and to ensure timely processing and completion of Change Controls
  • Coordinates cross-functional department meetings to prioritize Change Controls based on risk and business need
  • Reviews communications between Regulatory Affairs and the Regulatory Agency and compare to open Change Controls
  • Responsible for verifying and entering closure requirements for all Change Controls which includes knowledge and understanding of various site system processes and documentation (Wisdom, TevaDoc, EAM-Datastream, Oracle, Global Insight)
  • Maintains a current list of overdue and pending Change Controls and follows-up as appropriate to ensure completion in a timely manner
  • Provides leadership, training and guidance as required to end users to support daily functions
  • Trouble shoots and provides support as needed to business users answering questions concerning workflow processing/activities
  • Supports other Quality Systems/Regulatory Compliance activities as needed, such as Change Control, Auditing and APR assistance
  • Uses data trends to work with Site and Regulatory Affairs personnel to facilitate process improvements and lean concepts
  • Participates in cross functional improvement and process monitoring teams to mitigate unfavorable trends
  • Provides guidance and direction for Regulatory impact at the site level
  • Contributes to a motivating work environment, where superior performance is defined, supported, rewarded and recognized
  • Participates in external and internal audits
  • Review Applicable Standard Operating Procedures and other cGMP documents for process accuracy
  • Working knowledge of TrackWise and Regulatory Filing Requirments highly desirable
  • Detail oriented team player with strong interpersonal skills
  • Demonstrated working knowledge of cGMP and applicable regulatory requirements
24

Regulatory Affairs Associate Resume Examples & Samples

  • Route review materials to assigned PARC team members within established timelines
  • Schedule and manage PARC meeting dates/times and issue PARC agendas in a timely manner
  • Assure that all required activities leading up to PARC meetings are successfully completed within established timelines
  • Assure that all PARC review team comments are addressed and understood by PARC participants
  • Document any final changes to the materials and any outcomes of PARC discussions and route materials for final disposition
  • Review and approve material proofs to ensure that all PARC requested changes have been properly incorporated
  • Prepare and manage submissions to the US Food and Drug Administration Office of Prescription Drug Promotion (FDA OPDP) within established timelines
  • Proactively work with the responsible functions to assure that materials are expired or renewed in accordance with established procedures and timelines
  • BA/BS Degree
  • Three (3) to five (5) years of direct experience with processes related to the review and approval of prescription drug advertising and promotion materials preferred
  • Strong working knowledge of at least one electronic review system designed for advertising and promotion materials (Veeva Vault or ZINC) preferred
  • Working knowledge of the FDA 2253 submission process preferred
  • Ability to work under pressure and adhere to deadlines
  • Ability to work well in teams, including but not limited to peers and PARC membership
  • Demonstrated organizational and problem-solving skills
25

Drug Regulatory Affairs Associate Resume Examples & Samples

  • Prepare and complete the necessary documents (registration documents, Certificate of Pharmaceutical Product (CPP), Good Manufacturing Practice (GMP), Manufacturing License, etc.) for registration submission to local Head Authority in collaboration with Global Function (Pharma Development Regulatory (PDR), Pharma Technical Regulatory (PTR), International Product Partners (IPP)
  • Ensure regulatory compliance of Roche product registration process with BPOM regulation
  • Ensure that submission and follow up application to BPOM are performed in a timely and professional manner
  • Update the registration database and status (internal database, Global Product Regulatory System (GPRS)) in a regular basis
  • Support Marketing for tender documentation and supply chain for any queries related with registration approval status which will have impact to stock
26

Regulatory Affairs Associate, CMC & Labeling Resume Examples & Samples

  • Performs regulatory CMC and Labeling activities for assigned products and territories, including creating and updating quality sections of regulatory filings and review of quality submission documents to ensure consistency with related filings and regulatory requirements
  • Interacts with UT manufacturing and quality groups, contract and partner organizations, as necessary, regarding CMC and labeling regulatory issues
  • Collaborates with regulatory CMC and Labeling Manager on regulatory aspects of clinical and commercial product labeling for UT products
  • Ensures labeling remains current and consistent with regulatory filings
  • Assists in dossier preparation for partner companies in worldwide territories, ensuring accuracy and consistency
  • Proficiency with document management applications and MS Office
  • Diverse experience including biologics and drugs
  • Familiarity with operational systems (e.g., Master Control, LIMS, Adobe Illustrator)
27

Regulatory Affairs Associate Resume Examples & Samples

  • Support the compilation, development, submission, and maintenance of worldwide regulatory filings
  • Track regulatory project status and informational documents
  • Coordinate required documentation in coordination with CMC Team or Functional group
  • Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time
  • Interfacing with global Regulatory partners and internal cross functional teams
  • Attending relevant functional area and project team meetings as required
  • Bachelor’s or Master's Degree in a scientific discipline, or equivalent experience is required
  • Minimum of 2-4 years Regulatory Affairs experience required
  • Clear understanding of content and organization of regulatory submissions in eCTD format, as well as ICH and FDA guidances
  • Experience with global regulatory submissions (INDs, CTAs, MAAs, DMF’s)
  • Attention to detail, organizational skills, and a demonstrated ability to prioritize multiple projects
  • Motivated, self-starter, able to work independently with minimal supervision
28

Regulatory Affairs Associate Resume Examples & Samples

  • Establish and/or maintain relationships with health authorities
  • Represent department at all appropriate cross-functional team meetings and communicated with key stakeholders as required to provide valuable regulatory expertise
  • Represent department at required meetings and maintained communications on an ongoing basis
  • Communicate key departmental information to internal and external customers according to the Regulatory Standards as required
  • Attend external seminars and workshops as required and shared knowledge between team members
  • Provide departmental training to Roche employee as required
29

Regulatory Affairs Associate Resume Examples & Samples

  • Develops and/or revises core labeling text in accordance with the listed drug or OTC monograph using appropriate reference or source documents, ensuring compliance with all applicable regulations and company or customer style requirements
  • Initiates and compiles required labeling documents for all ANDA submissions necessary for commercially marketed products. This includes but is not limited to coordination of side-by-side comparisons, SPL, and other required submission materials, as necessary
  • Prepares full responses to triggered FDA labeling deficiency letters for commercially marketed products or listed drug updates via a supplement or amendment
  • Initiates required qumas/trackwise change controls relevant to area of responsibility
  • Serves as back up to the RA Coordinator for the filing of all MLS’s and labeling samples as well as the updating of required revision lists needed for the Elizabeth plant
  • Interfaces with necessary Actavis Divisions (e.g., Purchasing, Marketing, QA, 3rd Party QA, Supply Chain, Medical Affairs, etc.) and customers to ensure accuracy with all OTC labeling
  • Works with site engineering groups on labeling specifications, when needed
  • Establishes and maintains a filing system for all artwork approvals and labeling samples accordingly
  • Ensures compliance with all SOPs
  • Assists in the creation and/or revision of SOPs, as appropriate
  • Shares responsibility in the maintenance of master labeling text, history, and source files
  • Maintains knowledge of regulations, guidelines, and standard operating procedures applicable to generic labeling
  • Electronically monitors the FDA website for updates related to Rx/OTC labeling and communicates to affected company individuals accordingly
  • Individual must be able to multi-task in a fast paced work environment
  • Must have exemplary oral and written communication skills
  • Must be organized with a keen attention to detail
  • Must have the ability to work independently as well as in a team environment
  • Have knowledge of US FDA regulations in regard to creation of labeling and processes for ANDAs and NDAs
  • Individual must have proficiency with XML, database, and word processing applications as well as Adobe Professional. Creative Suite software packages on a PC platform preferred but not required
  • PC, Microsoft Office Suite with a proficiency in Microsoft Word and Microsoft Excel
  • Adobe Acrobat Professional
  • Knowledge of SPL or equivalent XML application used to create structured product labeling preferred
  • Adobe Creative Suite (Illustrator and Photoshop) preferred but not required
  • Quark Xpress preferred but not required
30

Global Regulatory Affairs Associate Resume Examples & Samples

  • Develops and proposes regulatory success path to his/her line manager, ensuring appropriate and relevant legislative and technical elements are identified and incorporated utilising regulatory intelligence and experience
  • Is responsible for the efficient and effective, execution as well as project management of post approval maintenance regulatory activities, to ensure successful delivery of assigned projects and activities within agreed timelines
  • Utilises his/her understanding of stakeholders as well as product expertise to deliver excellent regulatory support and maintain the base of our business healthy
  • Develops good working relationships with peers and external contacts to become a recognised business partner, proactively guiding them through existing regulatory requirements and raising awareness of upcoming changes to legislation and regulatory environment directly affecting our daily business
  • Use regulatory expertise to assess the impact of changes proposed by business partner or by new regulation, identify and communicate related risk and feeds into action plans to manage them efficiently
  • Operates in line with departmental SOPs. Contribute to the quality assurance in place in the department (e.g. identify gaps, areas for training and improvement of processes.…)
  • Support as required other regulatory functions in developing, reviewing and/or executing regulatory activities to strengthen the efficiency and quality of the regulatory function globally
  • Drives, with the support of his/her line manager, his/her personal development to ensure outperformance. Develops his/her regulatory knowledge and contributes to RB regulatory intelligence
  • Working in a fast paced FMCG environment to ensure that a product remains compliant during its lifecycle post approval, with no loss of supply due to a regulatory reason
  • Keeping on top of the ever changing regulatory environment and ensure that all relevant information is applied to all necessary product and dossier updates
  • Meeting business / project deadlines in a pressurised environment
  • Building relationships across Regulatory, the wider R&D community, and supply functions within RB
  • Life Science or Chemistry degree, or equivalent
  • Regulatory or R&D experience with Consumer products ideally including proven expertise in registration, notification or maintenance of regulatory dossier or technical documentation
  • Technical Competencies
31

Regulatory Information Management Latin Support Regulatory Affairs Associate Resume Examples & Samples

  • Provides support for key Global Regulatory Affairs system to ensure that data aligns with industry best practices and existing Work Instructions; oversees quality of system data by identifying inconsistencies and suggesting resolutions; responds to system users’ requests for changes to data and questions relating to GRA systems and data
  • Is a contributing member of project teams as a representative for Regulatory Information Management Team (i,e, Support Lead)
  • Bachelor’s Degree in Life Sciences or Information Technology Preferred. MS in scientific or information technology discipline preferred
  • Experience in system support
  • 5-7 years of Regulatory experience in the pharmaceutical industry, preferably with emerging markets (LatAm, APAC, CIS)
  • Experience with key systems supporting Regulatory activities: Regulatory Information Database, Submission publishing, Document Management systems
  • Experience working in Liquent’s InSight suite of tools desired
  • Regulatory publishing experience a plus
  • Must posess strong communication skills: Native fluency in English and in Spanish – mandatory; Native fluency in Portuguese desired but not required
  • Understanding of regulatory business processes
  • Working knowledge of regulatory requirements in the LatAm region desired
  • Understanding of the drug development process, generics and branded product development a plus
  • Ability and willingness to travel up to 20% within Latin American region as required
32

Regulatory Affairs Associate Resume Examples & Samples

  • Regulatory consultation
  • Regulatory compliance review/evaluation and gap analysis, including label, common technical documents, study report, and etc
  • Regulatory information collection and sharing
  • Cooperate with Clinical Lead and project team to set-up submission timeline and ensure the timeline is achieved as scheduled
  • Highlight common issues and address these with the team as a training need
  • Raise concerns with the Project Manager/Clinical Lead as appropriate
  • 1year or above RA experience
33

Regulatory Affairs Associate Resume Examples & Samples

  • You will ensure timely request and submission to Health Authorities of all registrations items required for new products, new indications, line extensions , you will monitor the registration process in order to obtain regulatory approvals in due time
  • You will ensure timely submissions and approvals for upcoming product variations and product renewals
  • You will identify, request and follow up on required items for various regulatory activities
  • You will establish effective communication network with internal partners, interacting with various functions to support business, Business Development, Marketing, Pricing, Field Operations, and Supply Chain
  • You will use and implement appropriate SOP’s as required by Global Policies and local regulations
  • You will ensure the local label creation and packaging development will meet the local and corporate criteria’s
  • You will validate of packaging material at the LNCPP
  • You will support responses and issue resolution with regulators
  • You will archive documents (i.e. documents related to the quality aspects of whole sale activities, regulatory documents and others) according to the local regulation and global requirements
  • You will submit and follow up promotional materials and ensure timely approvals
  • You will timely declare events
  • You will prepare regulatory documentations for submission of tenders and importation programs
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Senior Regulatory Affairs Associate Resume Examples & Samples

  • BA/BS in a scientific, healthcare or related field or equivalent experience; advanced degree preferred
  • At least 3 years of relevant regulatory affairs and drug development experience or equivalent biopharmaceutical experience, with a strong emphasis on regulatory affairs and drug development
  • Knowledge of US FDA regulations and guidance on drug development and the approval process for NDA/BLAs as well as postmarketing supplements
35

Quality & Regulatory Affairs Associate Resume Examples & Samples

  • Maintains complaint systems software and database
  • Analyzes, assesses and recommends improvements of the complaint management process
  • Prepares and submits medical device reports (MDR – FDA Form MedWatch 3500A, 21 CFR 803)
  • Analyzes and collaborates with a cross-functional team for market risk concerns through the compilation of Health Hazard Evaluations (HHE)
  • Participates in global Field Corrective Action and Recall Assessments and actions as required
  • Proactively distributes important product and/or medical information to relevant internal functions as necessary in support of product changes, safety issues and other sentinel events
  • Responds to both written and phone inquiries from Health Care Professionals, patients, and consumers
  • Disseminates relevant product complaint information within the organization on a consistent basis
  • Compiles statistical analysis of product complaints, prepares trend analysis, and contributes to management reports on the effectiveness of the complaint management system
  • Participates in risk analysis (e.g., establishing risk documents such as hazard analysis and FMEA)
  • Contributes to the development and maintenance of standard and custom product information responses in various formats to address vast array of inquiries
  • Participates in complaint process SOP writing and ensures that all employees are trained on the complaints processes
  • Participates in audits including, internal, US FDA, international agencies (including KFDA, JPAL, ANVISA, etc.) and ISO 13485
  • Plans, schedules, and completes projects in an aggressive “sense of urgency manner” consistent with corporate objectives
  • Participates in regulatory reviews, compliance gap analyses, implementation planning, and project management to ensure compliance with applicable regulatory requirements
  • Technical Skills – Must be able to review systems, processes and policies to ensure compliance with required quality system and clinical practices. Ability to make compliance decisions independently. Demonstrates understanding of manufacturing operations and scientific processes to assist with investigations, documentation, and reporting
  • Communication – Communicates effectively at all levels of the organization, including for purposes of facilitating audits, trainings, compliance and support corporate objectives. Expresses ideas clearly and simply both verbally and in writing. Promotes timely, ongoing flow of information to others. Communicates and listens effectively in order to develop and maintain key business relationships
  • Trust and Integrity
  • Problem Solving – Uses rigorous logic to solve problems. Probes all sources for answers. Looks beyond the obvious. Enjoys solving tactical and process problems. Applies appropriate theory and principles, expert judgment, and cross-functional expertise to address a broad range of complex problems
  • Decision Making – Quick to evaluate circumstances and seek necessary information or resources to secure a full understanding of the situation and/or requirements to be resolved. Makes timely, sound decisions based on analysis, wisdom, experience and judgment. Utilizes a high degree of creativity and latitude. Relies on extensive experience and good judgment to ensure that expectations are met and that business objectives are achieved
  • Adaptability – Must be very reactionary and adaptable to abrupt changes, arising issues, extreme time pressures, and other exigent circumstances while effectively maintaining the state of control required for the Complaints Handling System effectiveness. Embraces and adapts to change and demonstrates a willingness to learn. Reactionary and adaptable to abrupt changes, arising issues, extreme time pressures, and other exigent circumstances. Ability to respond quickly to change, and to prioritize actions to meet customer needs
  • Analytical Skills – Basic understanding of statistical tools. Proven ability to analyze and interpret data, to provide guidance, data driven decisions, and recommendations to internal customers, contract manufacturers, and external suppliers. Identifies and understands relevant trends, opportunities, needs, and market direction within the medical device industry
  • Computer Skills – Strong computer literacy. Highly proficient in MS Word, Excel, PowerPoint, Outlook required. High computer literacy as it relates to database management and generating electronic submissions
  • Minimum of 4 years of experience managing complaint management processes in the medical device or related industry required (e.g., QSR (21 CFR 820) and ISO/EC (MDD, ISO 13485))
  • Knowledge and understanding of FDA regulations and reporting requirements for medical device complaints, including MDR reports required
  • Knowledge of EU Medical Device Directives, Canadian Medical Device Regulations and other International Regulations strongly preferred
  • Knowledge of the requirements for international quality systems, including ISO 13485, MDD, Vigilance Systems, Notified Bodies, CE marking and IEC 60601 strongly preferred
  • Experience interacting with Health Care Professionals, patients, and consumers to complete and close complaint investigations strongly preferred
  • Experience with complaint management software systems and databases preferred
  • Basic understanding of statistical tools strongly preferred
36

Senior Regulatory Affairs Associate Resume Examples & Samples

  • Preparation, submission and maintenance of registration applications to the Therapeutic Goods Administration (TGA) and Medsafe (New Zealand) within the agreed timeframes assigned by the Regulatory Affairs Manager/Regulatory Affairs Team Leader
  • Review of existing registration dossiers to identify administrative and technical deficiencies that may influence the likely success or failure of the application
  • Propose/implement strategies to overcome deficiencies in the registration dossiers
  • Liaison with international parent and licence companies for the acquisition of documentation, information, product samples and responses to issues raised during review/evaluation of registration dossiers
  • Creation and review of Product Information and Consumer Medicine Information documents for registered products
  • Preparation of Artwork for submission and approval of artwork for final print
  • Responding to Medical Information enquiries
  • Preparation of the applications to the Pharmaceutical Benefits Branch for product reimbursement
  • Provision of guidance, training and coaching to junior Regulatory Affairs staff; and
  • Provide strategies with respect to necessary bioequivalence studies; to organize local bioequivalence studies, and preparation of such studies, eg provide guidance on study design and study conduct to international study centers; assisting HQ in conducting global BEQ studies where applicable
37

Regulatory Affairs Associate Resume Examples & Samples

  • Provide input to Global and local RA strategies. Assess potential risks and provide input for product development plans. Review regulatory project plans/protocols and reports to meet Canadian regulatory requirements in collaboration with Global and local partners
  • Prepare high quality submissions including NDS, SNDS, Medical Device Licence Applications, CTAs, etc. according to current Health Canada requirements. Collaborate with global and local teams to provide accurate responses to stakeholders within set deadlines
  • Assess proposed product, process and manufacturing site changes and execute necessary actions for implementation. Support Third Party efforts
  • Support continuous improvement initiatives by actively participating on local and global cross-functional project teams ensuring milestones are met. May be required to lead small projects (e.g. RFPs, JDE/PEGA. SOPs). Establish and/or improve local processes by reviewing, providing input and/or drafting departmental/cross-functional SOPs and Global procedures
  • In collaboration with Marketing, Medical Affairs and other business partners review and approve labeling and promotional material for regulatory compliance. Compile materials required for Annual Drug / Device Notifications, Yearly Biologic Product Reviews and Site License Renewals
  • Participate in driving compliance with the quality system within regulatory affairs in assigned areas of responsibility. Organize and maintain regulatory documentation in a format consistent with current RA practices and Baxter processes. Administrative duties as assigned
  • Maintain awareness of current regulatory environment and guidelines that impact the Industry, the RA Department and Baxter. Analyze, provide input into and compile comments for proposed regulations, guidance documents and policies. Maintain close communication with both internal and external business partners and build solid advocate network to drive outcomes
  • University degree in Science and / or relevant work experience
  • Science Degree (e.g. Pharmacy, Chemistry, Biology, Pharmacology)
  • Knowledge of Canadian Food and Drugs Act and Regulations and Medical Device Regulations as well as Health Canada policies and guidelines
  • Ability to interpret and apply Health Canada regulations, policies and guidelines
  • 1 year work experience
  • Ability to work in a fast-paced dynamic environment
  • Excellent time management skills and a sense of urgency
  • Ability to manage multiple projects and deadlines
  • Strong organization skills and ability to prioritize workload
  • Accuracy and attention to details
  • Proficient computer skills including MS Office Applications
  • Excellent interpersonal and collaboration skills
  • Ability to work independently and self-motivated to achieve results
  • Strong critical thinking and problem solving skills
  • Strong scientific knowledge
  • Good business acumen
  • Excellent Word / MS Project and database management skills
  • Strong Project Management skills
  • Ability to deal with ambiguity
38

Senior Regulatory Affairs Associate Resume Examples & Samples

  • Provides support for US and Canada market product registration activities (e.g., PreMarket Notification [510(k)], PreMarket Approval (PMA), New/Amended Medical Device License Applications)
  • Works with project teams for New Product Development, Sustaining, and VAVE projects to ensure alignment of business needs and regulatory requirements by providing regulatory input through the lifecycle of the project
  • Assists global partners with the preparation of regulatory documentation, including completing literature searches to support submissions
  • Completes review of labeling content, product and process changes, and product documentation
  • Maintains regulatory files in a format consistent with requirements
  • Manages facility licensing activities (e.g., Establishment Registrations, Product Listings, Export Certificates (Certificates to Foreign Governments [CFGs])
  • Develops processes and checklists, and creates procedures to assure early visibility for regulatory requirements related to claims identification and substantiation, labeling, promotional materials, and assuring the validity of clinical, ethical and regulatory compliance issues
  • Works with Global Regulatory counterparts to assure product compliance internationally
  • Provides regulatory support for internal and external (Regulatory Agency) audits, and assists with resolving observations
  • Evaluates and implements procedures pertaining to corporate and departmental regulatory activities
  • Adaptability
  • Collaboration and Teamwork
  • Analytical Skills – Strong analytical skills. Identifies and understands relevant trends, opportunities, needs and market direction within the medical device industry. Proven ability to analyze and interpret data, to provide guidance, data driven decisions and recommendations
  • Healthcare Industry Knowledge – Understanding of key business issues that exist in the medical device and healthcare industries, i.e. health care economics and trends, state and local laws, regulatory requirements. Link and apply complex technologies to business strategies
  • Computer Skills – Proficient computer system based tools including Microsoft Office applications, presentation, e-mail, web browsers and spreadsheet software. High computer literacy as it relates to database management and generating electronic submissions
  • Minimum of 6 years’ regulatory experience in the food, drug, or device industry, preferably related to medical device license/clearance requirements
  • History of success in making change and achieving objectives required
  • Successful track record working in a matrix/collaborative environment required
  • Software system familiarity, including Learning Management Systems, Document Management Systems, Database systems (e.g., ComplianceWire, Documentum, Microsoft Access)
39

Regulatory Affairs Associate Resume Examples & Samples

  • Coaches and mentors other associates. Trains less senior associates to review change requests and provides guidance to other associates in the preparation of other FDA submissions
  • Evaluates changes to regulatory documents and formulates strategies to maintain submission goals
  • Interacts with FDA and all Teva sites via written and phone communications
  • Approves IIG ingredients and assures that they are in accordance with the FDA database
  • Other duties, as assigned, or as business needs require
  • Timely submissions and expeditious approvals
  • Assists in developing less senior associates into fully contributing staff
  • BS in a scientific discipline or equivalent education and related experience
  • Minimum of three years in a Regulatory Affairs pharmaceutical environment with Analytical, QA, R&D or production experience preferred
  • Possesses strong critical and logical thinking
  • Demonstrates thorough knowledge of all FDA requirements pertaining to submission of regulatory documents
  • Demonstrates excellent organization skills and the ability to multi-task; detail oriented
  • Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts
  • Shares concepts, ideas, information, and suggestions with management, peers and others
  • Demonstrates the ability to evaluate regulatory documents and determine appropriate action
  • Demonstrates the ability to provide regulatory assessment to other departments with little or no supervision
  • Demonstrates the ability to coordinate submissions independently in a time intensive situation
40

Senior Regulatory Affairs Associate / Manager Resume Examples & Samples

  • Minimum BS degree in scientific or healthcare discipline
  • Ph.D., or Pharm.D degree preferred
  • Pharmaceutical / biotechnology industry experience, which shall include 3 years’ experience filing ANDA and 505 (b)(2) applications and obtaining approvals
  • Knowledge of chemistry, manufacturing and controls, as needed for ANDA submissions
  • Post approval experience #LI-SA
41

Senior Regulatory Affairs Associate Resume Examples & Samples

  • Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures
  • Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations preparing or contributing to preparation of original clinical trial applications and contributing to preparation of marketing authorizations
  • Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license for assigned products and territories
  • Responsible for updating Regulatory databases, systems and archiving
  • Participate in group meetings and present project status updates and strategic approaches to moderately complex programs/projects
  • Responsible with manager for development and acquisition of required regulatory skills and knowledge
  • May initiate or contribute to local process improvements, which have a significant impact on the working of the Regulatory Affairs function or other departments
  • Responsible for product information activities such as: translations review, implementation and change control of product information, and packaging material review
  • Past experience on safety information processing is a plus
  • Extensive relevant industry experience
  • Degree in a scientific field is preferred
  • Excellent organization skills and ability to work on a number of projects with tight timelines is required
  • Excellent verbal and written communication skills and interpersonal skills are required
  • Very good verbal and written English is required
  • Must have a reasonable understanding of regulatory requirements
  • Good knowledge of regulatory systems is preferred
  • Work is performed under the general supervision of more senior Regulatory Affairs professionals
42

Temporary Regulatory Affairs Associate Resume Examples & Samples

  • Collection, review and preparation of documentation in support of regulatory CMC submissions to regulatory agencies in the EU, US and other international agencies
  • Regulatory support for R&D team for development projects
  • Regulatory support for third parties for out licencing activities
  • Create timelines and tracking deliverables to ensure that all submissions are submitted on-time
  • Review and approve change controls related to proposed products/process changes and their impact on specific regulatory applications
  • Plan and initiate projects based on consultation with Manager
  • Update and maintain regulatory information management system as part of on-going responsibilities
  • Attend relevant functional area and project team meetings as required
  • Participation in initiatives aimed at improving internal regulatory standards
  • Maintain departmental cGMP documentation and participate in cGMP project initiatives
43

Senior Regulatory Affairs Associate Resume Examples & Samples

  • Provide the regulatory support for brands
  • Ensure on-going regulatory compliance of product portfolio
  • Support the resolution of regulatory issues affecting products
  • Provide regulatory support to internal and external customers in a business oriented way
  • Work closely with external authorities, partners, contractors and licensees to ensure that regulatory matters are properly managed and issues resolved
44

Senior Regulatory Affairs Associate Resume Examples & Samples

  • Medical writing
  • Controlled substances (e.g. DEA)
  • Import / export
  • Regulatory history, guidelines, policies, standards, practices, requirements and precedents
  • Principles and requirements of applicable product laws
  • International treaties and regional, national, local and territorial trade requirements, agreements and considerations
  • Domestic and international regulatory guidelines, policies and regulations
  • Ethical guidelines of the regulatory profession, clinical research and regulatory process
  • Communication Skills or Ability to
  • Communicate effectively verbally and in writing
  • Communicate with diverse audiences and personnel
  • Write and edit technical documents
  • Work with cross-functional teams
  • Negotiate internally and externally with regulatory agencies
  • Cognitive Skills or Ability to
  • Manage projects
  • Create project plans and timelines
  • Think analytically
  • Organize and track complex information
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
  • Has broad knowledge of various technical alternatives and their potential impact on the business
  • Exercise good and ethical judgment within policy and regulations
  • Use in-depth knowledge of business functions and cross group dependencies/ relationships
  • Define regulatory strategy with supervision
  • Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues
45

Regulatory Affairs, Associate Resume Examples & Samples

  • Serves as an Associate RA representative on project teams
  • Maintains Regulatory Affairs documentation
  • Assist in the preparation of division procedures to ensure compliance with Regulatory and Corporate requirements
  • Performs on special projects as required
  • No previous regulatory experience is required
  • Ability to plan and schedule multiple priorities in a concurrent fashion
  • Complete work with minimal supervision and ability to work independently
46

Regulatory Affairs Associate Resume Examples & Samples

  • Provides internal regulatory oversight and support to his/her assigned products as well as direct input in areas of his/her expertise
  • Functions as the Compliance resource for the assigned products and is expected to be aware of global regulatory agency publications, proposed guidance, inspection reports, and determine trends and areas of compliance emphasis that could affect his/her assigned products. The incumbent is expected to proactively recommend courses of action to implement/improve JM compliance with new regulatory requirements for his/her assigned products
  • Review and approve the development reports, control procedures, processing procedures, validations, test methodologies, equipment qualifications, and other required documentation which are necessary to both develop a product and also successfully transition it into routine commercial manufacture. The incumbent shall prepare and approve global regulatory submissions and technical packages for customers which describe the manufacturing and control procedures used to manufacture his/her assigned products. The incumbent must be able to successfully defend these documents when questioned during customer audits and regulatory agency inspections
  • Advises management on the best course of action and preparing responses and correspondence
  • Functions as a regulatory representative for the Change Control, Deviation, Out of Specifications (OOS), and Trackwise® systems for his/her assigned products
  • Prepares periodic product review for his/her assigned products
  • Is knowledgeable of the regulations pertaining to the API industry, including but not limited to ICH Q7, M4 and related guidance, FDA regulations, etc
  • Provides technical knowledge to all departments when developing regulatory policies and procedures
  • Ensures site regulatory policies and procedures are compliant with state and federal requirements, including but not limited to GMP, DEA, FDA, etc
  • Reviews all investigations and documentation to ensure compliance with Johnson Matthey’s Standard Operating Procedures (SOPs), all state and federal regulations
  • Provides guidance to all departments on regulatory-related issues
  • Is knowledgeable in the understanding of all EH&S policies and procedures
  • Ensures that all job activities comply with any EH&S related rules and regulations that pertain to the department
  • Support the Company’s commitment for environmental health & safety by applying ISO 14001 and Sustainability 2017 principals into daily activities
47

Regulatory Affairs Associate Resume Examples & Samples

  • Preparing ANDAs and amendments for FDA submission
  • Evaluating change controls and provide regulatory assessment
  • Performing labeling review
  • Performing special projects assigned by Regulatory Affairs management
48

Regulatory Affairs Associate Resume Examples & Samples

  • Preparation and submission of CTD dossier style packages to customers and eCTD dossiers direct to TGA for OTC and Registered Complimentary applications
  • Preparing and maintaining regulatory documentation to support Catalent and customer products \licences
  • Providing Regulatory advice and support to internal and external customers from development through full life cycle management
  • Accurately, listing (AUSTL)/registering (AUSTR) products in eBS and maintaining records on the ARTG as required
  • Applying for, obtaining and keeping current licences and permits at all times
  • Preparing and maintaining GMP Agreements and Product Quality Reviews, with all Catalent customers (as an approved delegate of the Regulatory Affairs Manager)
  • Managing key Quality & Regulatory projects as identified
  • Providing advice, guidance and education to others on regulatory matters
  • Degree in Pharmacy or Science or equivalent
  • Experience working in a GMP environment
  • Proven experience in Pharmaceuticals with accountability for compliance and/or regulatory affairs
  • Demonstrated experience working with CTD format information (experience in writing bioequivalence justifications/biowaivers would be an advantage)
  • Demonstrated competency using actual or like IT systems such as; eCTD Manager, Manage, ComplianceWire and TrackWise, or equivalent systems
  • Demonstrated competency using MS Office Computer skills - spreadsheets (Microsoft Excel), scheduling (Project) word processing, graphics (PowerPoint) and email (Outlook)
  • Demonstrated ability to work productively with others, utilising a consultative/participative approach
  • Demonstrated ability to generate rapid, positive change within an organisation. In particular, the ability to generate change through a collaborative and participative team approach
  • Project management experience would be highly regarded
  • Ability to network effectively at all levels, and represent the company in a professional manner at all times, both on and off site
  • Demonstrated Continuous Improvement experience
  • Demonstrated ability to build effective relationships
  • Demonstrated ability for effective oral and written communication skills
49

Regulatory Affairs Associate Support Resume Examples & Samples

  • First point of contact for Country Operations Regulatory Affairs (CORA) arranging and providing all necessary documentation required in support of obtaining and maintaining product registrations, in line with the licensing strategy
  • Executing all regulatory procedures in the EU (new licensing/maintenance)
  • Expert in country/regional regulatory requirements and
  • Keeping oversight of all regulatory activity in countries worldwide
  • Submission strategy for new products in alignment with other GRA teams
  • Organize and manage all typical administrative tasks for the GRA teams in Boxmeer like meeting organization, travel arrangements, travel cost management etc
  • Manage purchase orders in SAP-SRM and ensure archiving where necessary
  • Extract data from the regulatory databases, organize data and provide overviews as required. Format presentations
  • Actively exchange with our CORA regulatory information as well as provision- and tracking and tracing of data and documents
  • Maintain and quality control of archiving systems
  • Will be part of the GRA Support Team consisting of two other colleagues dividing the workload
  • MBO+ work and thinking
  • Minimum 3 years’ experience in a similar function
  • Committed, accurate, service-minded, pro-active attitude and easy approachable
  • Solid experience with Office software and the ability to learn new systems
  • Communication in Dutch and English
  • Capable of discreetly handling confidential information
  • 0,8 FTE Minimum
50

Regulatory Affairs Associate Resume Examples & Samples

  • BS/BA degree in an engineering or scientific discipline with 0-2 years of experience in International regulatory affairs/compliance, preferably in Latin America. Experience in product complaint handling, documentation and reporting is strongly preferred
  • Basic knowledge of FDA, ISO, EU regulations pertaining to medical devices
  • Strong regulatory compliance documentation skills. Experience in preparing regulatory submissions and associated documents legalization is preferred
  • Ability to handle multiple tasks and to prioritize and schedule work to meet business needs
  • General computer knowledge and working ability with MS office programs is required
  • Collaborate and execute regulatory strategies for global registrations and compliance with particurlar emphasis on international Markets
  • Work with local regulatory agents and distributors to assist in the preparation, compilation and maintenance of regulatory registrations in international markets
  • Obtain CFGs and co-ordinate document legalization to support international regulatory submissions
  • Complete change control documentation for regulatory related product and label changes
  • Have a basic understanding of pertinent ISO/FDA/EU/EPA regulations, standards and guidance documents that dictate compliance requirements for all Cantel products
  • Participate on project teams to provide regulatory input as assigned. Assist in the determination and definition of regulatory requirements for project teams and stakeholders throughout the organization
51

Post-market Regulatory Affairs Associate Resume Examples & Samples

  • BS degree in scientific, engineering or technical discipline with 0-2 years of experience in regulatory affairs, preferably in medical devices, or equivalent
  • Basic knowledge of U.S. regulations in the areas of the FDA and international regulations such as ISO 13485 and post-market surveillance and medical device vigilance is preferred
  • Demonstrate independent problem solving skills and solid written/verbal communication skills. Strong attention to detail
  • Experience in U.S. and international regulatory complaint handling and reporting is preferred
  • Completion of downstream regulatory compliance tasks to help achieve RA departmental objectives
  • Successfully assist and execute regulatory vigilance reporting, medical device reporting, complaint handling and product recall activities
  • Conduct complaint investigations with customers, field assurance team members for regulatory related documentation on product vigilance reports and complaints
  • Complete domestic and international downstream regulatory affairs and post-market activities for company product lines. Update and maintain essential requirements checklists and technical files for products sold in the EU market
  • Review and determine regulatory implications and requirements of product, labeling and/or other change control documentation or design changes
  • Participate on project teams to provide regulatory input as assigned. Prepare post-market regulatory strategies, plans, documentation and submissions for the products assigned
  • Support continuous improvement initiatives for downstream regulatory compliance processes
  • Assist in the development and maintenance of Safety Data Sheets required for Cantel Medical products in accordance with the latest regulations
  • Provide Regulatory support in the pre and post entry review of import and export compliance
52

Senior Regulatory Affairs Associate Resume Examples & Samples

  • Represent Regulatory Affairs on internal and external cross-functional teams, providing regulatory affairs support and strategy for investigational and/or marketed products for HIV, as assigned
  • Prepare IND and NDA submissions for assigned products, which may include routine submissions (e.g., safety reports, DSURs, PSURs/PBRERs, and NDA Annual Reports) as well as IND amendments and NDA supplements, as needed
  • Potential opportunity to support compilation and submission of new INDs and/or NDAs
  • Work within the department and with other functional areas on process improvements
  • Prepare regulatory submissions for assigned IND or NDA products, including routine submissions (e.g., PSUR/PBRERs, NDA Annual Reports, DSURs, etc.) as well as IND amendments and NDA supplements, as needed
  • Contribute to preparation and filing of original IND and/or NDA submissions, as required
  • Engage cross-functional teams (internal and/or external teams) to develop submission strategies for US submissions (as required) in line with ICH/regional requirements and company policies and procedures
  • Support development and/or revision of product labeling (e.g., USPI, CCDS/CSI) in accordance with ICH/regional requirements and in alignment with company policies and standards, as needed
  • Participate in team meetings (e.g., study management teams and regulatory submission/project teams) for assigned products, including development of regulatory strategy and presentation of ongoing project updates
  • Under guidance of immediate manager, oversee self-development and acquisition of required regulatory skills and knowledge
  • Initiate and/or contribute to local process improvements which have an impact on the Regulatory Affairs function and/or other departments
  • As necessary, liaise with FDA for assigned projects/products
  • Minimum of a BA/BS degree (an advanced degree is desirable)
  • Minimum 5 years of experience in Regulatory Affairs or related field
  • Excellent organizational, interpersonal, and communication skills
  • Ability to work independently on multiple projects with tight timelines and minimal supervision
  • General understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories
53

Regulatory Affairs Associate Director Resume Examples & Samples

  • Provide commercial regulatory knowledge, consultation, advice and risk assessments to the US organization, including senior leadership, that are aligned with corporate commercialization efforts
  • Collaborate with SSF cross functional teams, Field Sales team, as well as global teams in creating and reviewing promotional materials to ensure compliance with related corporate and regulatory requirements while meeting strategic promotional objectives
  • Work with cross functional teams to enhance systems, technology and processes
  • Represent Regulatory Affairs as a member and Chair of the Actelion Review Committee (ARC)
  • Provides guidance to members of the ARC regarding the current regulatory environment and regulatory considerations that may impact business activities
  • Provide regulatory oversight and advice regarding advertisement and promotion materials (e.g. marketing materials, education materials, institutional promotion, disease education, press releases, websites, speaker presentations)
  • Provide regulatory guidance to the Medical Review Committee (MRC)
  • Develop and refine consistent regulatory strategies for advertising and promotional of multiple marketed products; ensuring that labeling, promotion, and advertising materials conform to regulations, guidances and the lawEnsure Actelion’s regulatory processes are compliant with federal regulations pertaining to Subpart H, 2253, regulatory and risk management requirements
  • Provide direction and supervision to assure quality and timely submission (including electronic submission) of advertising and promotional materials to FDA in accordance with business objectives
  • Coordinate and lead communication with the relevant personnel at the FDA/OPDP to ensure successful interactions with the agency build a rapport and track evolving regulatory developments that impact the conduct of our business and inform senior management as appropriate
  • Identify potential areas of regulatory compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future
  • Ensure quality documents are defined, created, maintained and implemented globally in accordance with Actelion requirements. In addition, provide local input on global SOPs as appropriate
  • Coordinate corporate wide on-going regulatory training to SSF office, field colleagues, medical congress booth staff, as well as speakers and vendors on regulatory issues pertaining to promotion of Actelion products
  • Regularly monitor the regulatory compliance trends in the industry, interpret new regulations, guidance documents and enforcement activities, and evaluate the impact on the industry and the company
  • Work with Regulatory Management Team in development of Commercial
  • Regulatory strategies, policies, cross-functional projects, and interdepartmental decision-making
  • Act as liaison for temporary/contract workers
  • Bachelor's degree with at least 8 years biopharmaceutical industry experience, including at least 6 years in Regulatory Affairs; equivalent combination of advanced degree and less experience will be considered
54

Regulatory Affairs Associate Resume Examples & Samples

  • Reviews and prepares routine (e.g., investigator submissions, correspondence to FDA, etc.) regulatory submissions as well as supports senior-level staff in the preparation, QC, and submissions of major submissions (initial INDs, NDAs, sNDAs) for investigational and/or marketed drug products
  • Works with Supervisor to develop regulatory strategy on preclinical, clinical and/or CMC issues
  • Regulatory Intelligence (research regulations, guidance, precedence )responsibilities as assigned by Supervisor
  • Coordinates and supports the team in planning and preparation for FDA meetings or teleconference
  • Follows Teva Safety, Health, and Environmental policies and procedures
  • Other duties as assigned or as business needs require (e.g., support submissions for Health Authorities beyond FDA)
  • Bachelor’s Degree in scientific field or equivalent combination of education and related work experience- required
  • PharmD, or Master’s degree preferred
  • 2 years of pharmaceutical industry experience in new drug regulated product strategy and submissions; including working knowledge of FDA regulations and guidance for new drugs
  • Evolving understanding of regulations/guidelines governing development of pharmaceuticals preferred
  • RAPS RAC (U.S. or EU) certification beneficial, but not required
  • Demonstrates an understanding of ICH and FDA guidelines as well as FDA regulations (21 CFR) and GXPs
55

Regulatory Affairs Associate Resume Examples & Samples

  • Validate product composition and labeling compliance under US laws & regulations
  • Manage state licensing requirements for bottled water operations
  • Coordinate product and plant testing requirements for purposes of regulatory compliance
  • Participate in validation of new marketing campaigns
  • Validate new marketing materials and approve artwork/labels/graphics/claims
  • Develop product labeling master files (nutritional masters) for dairy products
  • Maintain and/or update current ingredient data and claim attributes in internal databases for dairy products
  • Contribute Regulatory perspective in brand and cross-functional meetings
  • Support the review and validation of product and packaging innovations
  • Develop and support internal and/or external education of the water category and the benefits associated with healthy hydration
  • Anticipate and help the business and NORAM teams prepare for changes in regulations
  • Support plants with US regulatory compliance questions
  • Train internal stakeholders on specific regulatory matters relevant to the business
  • Work with Public Affairs in supporting category defense and growth activities through trade associations
  • Work with suppliers to develop product specification information as it relates to regulatory claims for dairy products
  • Support the management of crises as needed
  • Knowledge of and experience with United States food regulations. Knowledge of bottled water regulation is preferred; knowledge of dairy regulation is a plus
  • Strong writing and presentation skills required
  • Fluency in French is a plus
  • Strategic thinker adept at working cross-functionally to achieve goals in a timely manner
  • Doer - Be creative, bring new or alternative solutions for business within the regulatory framework
  • Committed - seeks out needed resources to get job done
  • Open - Talk with honesty and without fear
  • Minimum of 4 years of experience in nutrition and regulatory affairs
  • Food science, biological science and/or nutrition background is a plus
56

Regulatory Affairs Associate / Project Leader Resume Examples & Samples

  • B.Sc. minimum in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
  • 3-5 years experience in drug regulatory affairs, including clinical and labeling submissions
  • Good working knowledge of the Canadian Food and Drugs Regulations, relevant policies and guidelines
  • Good understanding of the drug development and commercialization process
  • Ability to react quickly and provide creative solutions to problems
  • Able to manage multiple projects and tight timelines
  • Competence with the electronic business environment
  • Ability to work with diverse groups of individuals in a team
  • Provides input into the planning and supports preparation of regulatory submission (NDSs, SNDSs, CTAs, NCs, etc) to aggressive targets
  • Ensures regulatory compliance with HPFB requirements and alignment with business needs
  • Provides input into the development of submission strategies and works with others to negotiate with HPFB towards rapid approval with optimum labeling
  • Liaises with multiple local and global functional groups to ensure Canadian regulatory needs are met
  • Identifies and responds to issues related to assigned projects
  • Interprets Canadian regulations, guidelines and policies as they apply to GSK commercial activities
57

Regulatory Affairs Associate Resume Examples & Samples

  • Experience with at least one of; medicinal, cosmetic, medical device and food product regulations as required by the Category supported or significant adjacent experience in NPD, Quality, Medical, Toxicology within a Consumer Healthcare environment
  • Experience of working on similar or related products
  • Awareness of regulatory processes in at least one geography
  • Masters Degree or PharmD
  • 1+ years relevant experience
  • Acts as a Business Partner and provides regulatory advice to a project on aspects of drug/cosmetic/devices/foods and supplements development as appropriate
  • Develops regulatory strategies under supervision working within Project Teams in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams
  • Communicates effectively with the immediate functional team and within cross-functional Project Teams
  • Delivery of high quality core files to agreed timelines
  • Inputs to non-product related activities both within the function in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage
  • Support the full life cycle of products under supervision, including: maintenance activities; Design to Value, complexity reduction, engineering initiatives; change controls, Core File updates
  • Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions
58

Regulatory Affairs Associate Resume Examples & Samples

  • Bachelors degree, preferably Pharmacy, Chemistry or Biology
  • 3 plus years of relevant experience
  • Masters degree or higher
  • OTC drug, Monograph and/or dietary supplement Regulatory experience in US
  • Partners with the business to deliver regulatory outcomes
  • Performs with independent judgment and execution in a defined area which directly impacts the operational results of the business unit
  • May manage or mentor team members and provide day to day support and guidance
59

Senior Regulatory Affairs Associate Resume Examples & Samples

  • The preparation, submission and tracking of accurate and timely regulatory applications with a focus on the respiratory therapeutic area
  • Assisting with the development and implementation of global GSK regulatory strategy
  • The maintenance of registered products ensuring product compliance
  • Working closely with local brand teams and global groups to proactively manage and where appropriate create, the response to all regulatory questions received from the Australian Regulatory Authorities (TGA) and Medsafe (NZ) within an agreed priority and timeframe
  • To provide input and expertise to assist commercial, technical and marketing teams with new product initiatives and activities
  • A degree in pharmacy, chemistry or pharmacology with a strong preference for post graduate studies
  • First-hand experience with major submissions in Australia essential (NZ experience desirable)
  • Experience and subject matter expertise in regulatory affairs within the pharmaceutical industry specifically in the area of prescription medicines
  • Exceptional written and verbal communication skills with the ability to foster positive and proactive relationships with a broad range of stakeholders including the TGA, Industry Associations and a broad range of internal stakeholders
  • Strong analytical skills, excellent attention to detail and a commitment for compliance processes
  • Ability to think strategically and innovatively for resolution of regulatory issues
60

Regulatory Affairs Associate Resume Examples & Samples

  • Provides input into multiple Regulatory projects inclusive of EMA Policy 0070 clinical data redaction engagements
  • Authors, compiles and or reviews various Regulatory documents
  • Authors or reviews Accenture RA SOPs, internal guidance documents and training materials
  • Liaises with internal and external teams to meet project deliverables
  • Coordinates project timelines and workflows
  • Supports Regulatory Operations in the generation and assembly of all types of Global electronic submission filings including eCTD and NeeS
  • Maintains and updates metrics in appropriate databases
  • Archives all client data and documents in appropriate databases per appropriate Accenture or client SOPs
  • Assure standards adhere to Accenture and/or client SOPs and guidance
  • Bachelor’s degree in natural science, life sciences or pharmacy; advanced degree is preferred
  • Up to 2 years’ experience in pharmaceutical regulatory affairs. Additional relevant experience in a Life Sciences industry may be preferred
  • Knowledge in handling registrations and maintenance of pharmaceutical, medical device, consumer and/or cosmetic products from a global, regional and local perspective
  • Excellent international regulatory understanding and experience in handling business process excellence
  • Establishes excellent working relationships with peers and team members through integrity, credibility, reliability and trust
  • Establishes confidence in one’s regulatory abilities and develops long-term trusting relationships
  • Promotes the professional growth of self to achieve individual and organizational goals
  • Analytical/strategic skills
  • Ability to work on numerous projects and under pressure
61

Regulatory Affairs Associate Resume Examples & Samples

  • Support the compilation, development, and submission to FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws such as IND amendments, NDA supplements, annual reports
  • Create timelines and tracking deliverables to ensure that all submissions are done on-time
  • Represent Regulatory Affairs on internal and external cross-functional teams, providing regulatory support and strategy for investigational and/or marketed products, as assigned
  • Coordinate required documentation with CMC and other cross-functional teams to support global clinical trial application submissions, as assigned
  • Analyze new regulations and guidelines and make process improvement recommendations to the regulatory affairs group as assigned by supervisor
  • Prepare and deliver effective presentations for department meetings
  • Pays close attention to detail, strong organizational skills, and ability to prioritize multiple projects
  • Displays good interpersonal skills and ability to deal effectively with a variety of personnel
  • Demonstrates advanced knowledge and understanding of applicable regulations
62

Regional Regulatory Affairs Associate Resume Examples & Samples

  • Submit products files to MOH either for new registration or renewal and ensure that filing & submission meet local requirements & company objectives
  • Coordinate the preparation, review, submission and follow-up of regulatory files that are properly formatted and in compliance with local regulations
  • Be involved in all aspects of the application to take the product to market
  • Execute regulatory plans and manage timelines to achieve the stated goals
  • Ensure that relevant local regulations are properly communicated to the different stakeholders internally & externally
  • Respond to inquiries from the different HAs
  • Maintain archiving of correspondences and other records of all filings and interactions with regulatory authorities
  • Update regulatory databases, tracking tables & information systems
  • Develop & maintain relationships with Health Authorities & other relevant organizations
  • Maintain current knowledge of existing as well as emerging regulations, standards and guidance documents
  • Provide regulatory support to all company functions upon request
  • Comply with local laws & HCC guidelines, Foreign Corrupt Practices Act (FCPA), Policy on Business Conduct (PBC)
  • Ensure that all regulatory activities are conducted in compliance with relevant laws & regulations as well as J&J guidelines
  • Bachelor’s Degree from Medical related field
  • Past experience in RA field
  • Comprehensive knowledge of regulatory requirements, MOH regulations & guidelines
  • Strong knowledge base and skill set in science
  • Confident communication and presentation skills, both verbal and written
  • Demonstrated ability to manage multiple assignments
  • Strong interpersonal skills to deal with sensitive and occasionally contentious issues
63

Regulatory Affairs Associate Resume Examples & Samples

  • Bachelor’s Degree in a related, Communications or Scientific Discipline; or an equivalent combination of education and related experience
  • 3+ years experience in regulatory, quality assurance, quality control, or similar in a regulated environment
  • 1+ years experience in graphic arts or product labeling, or an equivalent combination of education and related experience, if applicable
  • Foreign language skills a plus
64

Regulatory Affairs Associate Resume Examples & Samples

  • Provides regulatory support and guidance to assigned device product teams
  • Determines regulatory pathway and provides complete global regulatory assessment of product changes, including submission of 510k packages, as appropriate
  • Provides regulatory support for international registrations and requests for documentation, and support for registration of portfolio products in new markets
  • Review and approval of product labeling and advertising
  • Minimum of three (3) years of medical device experience working in a regulatory, laboratory and/or quality function
  • Bachelor’s degree or higher Biomedical Engineering, Mechanical Engineering, Chemical Engineering or related discipline from an accredited institution
  • Basic understanding of FDA device regulations
  • Experience working with medical device hardware and/or software
  • Ability to work effectively in cross functional teams
65

Regulatory Affairs Associate Resume Examples & Samples

  • Work in close collaboration with the Associate Director, Regulatory Affairs and key stakeholders in the filing of quality submissions, effective problem solving and negotiations with Health Canada officials
  • Manage and lead approval of assigned new products and claims; manage changes to existing products which includes cosmetics, OTC drugs and Natural Health Products
  • Determine and communicate submission and compliance requirements to key stakeholders within the company and gather and compile necessary data
  • Monitor and influence Regulatory and External Environment; anticipate and proactively affect changes to the Canadian Food and Drug Act and Regulations, Policies/Guidelines, Cosmetic Regulations, Natural Health Product Regulations
  • Collaborate with and support JJI business partners to ensure that product claims and advertising are compliant, competitive and contribute to optimal marketing of products
  • Manage competitive complaints from and to regulatory authorities and competitors, in collaboration with legal and marketing
  • Maintain vigilant oversight of developments within the assigned therapeutic and/or functional area, communicating key competitive learnings to Marketing and Regulatory Affairs colleagues as appropriate
  • Keep abreast of all product changes and other issues relating to the sale and distribution of marketed products through Change Control processes and regular communication with colleagues (i.e. Marketing, Medical Affairs, R&D, QA/QC, Global Regulatory). Ensuring all the marketed products retain positive registration status in the changing regulatory environment and are in compliance with Canadian Food and Drug Act and Regulations and other applicable legislation (e.g. Environmental Regulations)
  • University degree in a scientific field (Life Sciences, Chemistry or, Pharmacy)
  • Approximately 2-3 years of progressive experience in Pharmaceutical Regulatory Affairs
  • Demonstrated experience in obtaining approval of a variety of submissions and in-depth knowledge of the Canadian Food & Drugs Act and Regulations., Natural Health Product Regulations, Cosmetic Regulations and HC guidelines and policies
  • Canadian non-prescription drug, Natural Health Products and cosmetic experience an asset
66

Senior Regulatory Affairs Associate Resume Examples & Samples

  • Sound basis of Regulatory and Scientific knowledge
  • Knowledge of regulations
  • Technical system skills (e.g. electronic document management, spreadsheets, databases, online research)
  • Manage multiple projects and deadlines
  • Bachelor’s degree or country equivalent in pharmacy or related scientific discipline with a minimum of 2 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization. Higher degree/PhD will be an advantage
67

Regulatory Affairs Associate Resume Examples & Samples

  • Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market
  • Analyse regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead development of strategies and plans to mitigate, so that we can deliver products backed by science that are robust and aligned with business needs
  • Actively contribute to high performing teams, including looking for ways to improve performance. May lead direct reports or cross-functional teams within local market
  • Build relationships with key stakeholders and represent GSK in a responsible manner according to company values, in order to communicate GSK CH policies and strategies and negotiate outcomes
  • Manage compliance within defined portfolio/activity streams in line with GSK CH expectations - support key processes and ways of working (eg, in relation to GSK CMC, quality, product labelling requirements as well as local MoH regulations). Propose solutions to identified issues and implement
  • Collaborative working together with other functions ( eg, marketing, supply chain) to deliver agreed NPD and value engineering projects
  • Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated
  • Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business
  • Maintain required regulatory compliance databases, systems and processes. Train other company stakeholders as required to build knowledge and compliant utilisation
  • Maintain high level of knowledge on the science of products within defined portfolio
68

Regulatory Affairs Associate Resume Examples & Samples

  • You have a passion for achievement; be entrepreneurial, self motivating and the integrity and drive with a strong desire to make things happen
  • You want to have accountability for leading and coordinating the resolution of regulatory issues and provide advice to the company on registration and compliance issues
  • You want to effectively communicate and collaborate with other functions within RB to ensure that the business remains compliant
  • Work on a range of RB Products such as Dettol, Finish, Vanish, Calgon, Woolite, Cillit Bang, Harpic, Air Wick, Veet, Clearasil, Scholl and E45 sold in the UK and Ireland
  • Work collaboratively with the relevant country teams to establish and implement the regulatory strategies within agreed timescales to bring competitive advantage to RB brands
  • Interpret and apply all relevant legislation in the UK to keep the RB business up to date on national regulatory trends, risks and opportunities
  • Responsible for the regulatory approval of promotional material
  • Provide regulatory support and advice to other functions to ensure products are maintained in compliance with the local requirements
  • Ensure compliance to all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products
  • To maintain the internal processes (such as issuing documents, updating databases)
  • To work with external agencies to correctly notify and register products in a timely fashion
  • Science degree in relevant scientific discipline and regulatory and product safety experience
  • Understanding of the current regulations, laws and industry requirements
  • Ability to manage workload and identify priority tasks to meet tight deadlines
  • Strong influencing / communication expertise
  • Ability to build good relationships and challenge constructively and confidently
  • Ability to consolidate large volumes of complex information, interpret & construct straightforward plans. Naturally inquisitive and interested in our brands
  • Confident and capable of operating at all levels and able to resolve conflict situations
  • Competent with PC tools and information systems
  • Ability to challenge the status quo and propose improvement
  • Able to apply appropriate problem solving techniques to evaluate and resolve operational issues
  • Experience in Household and/or Cosmetic goods
69

Regulatory Affairs Associate Resume Examples & Samples

  • Position will support new product development cross-functional project teams acting as the regulatory affairs team member including the development and execution of the regulatory strategy for both US and EU markets
  • Liase with cross-functional team to drive regulatory deliverables such as 510(k) submissions and EU Technical Files and/or Design Dossiers
  • Facilitate international registrations, assist with change control activities, and revise departmental procedures
70

Regulatory Affairs Associate Resume Examples & Samples

  • Work collaboratively with other functions and provide the regulatory support to enable delivery of ANZ business brand plans, Squeeze and Global Ingredient Removal projects
  • Ensure the regulatory compliance of ANZ products to bring competitive advantage to our brands
  • Amend registration dossiers as necessary for country-specific regulatory requirements, submit registration applications and negotiate with governmental authorities to obtain rapid approvals with favourable labelling and claims
  • Provide regulatory and product compliance expertise in the area of advertising and label claims for existing and new products
  • Assist with local statutory reporting requirements
  • Monitor and interpret local regulatory issues and trends that will impact the marketability of company products and ensure that the company is aware of significant regulatory issues
  • Interface with local government agencies and industry associations to assess the impact and implementation of required company compliance with all legislation and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products
  • Prepare, maintain and update local product registration and regulatory compliance files and databases
71

Regulatory Affairs Associate Resume Examples & Samples

  • Artwork
  • Data administration
  • Label Coordination
  • Committed to caring
  • Responsible to our communities
  • Unique in our background and experiences
  • Passionate about doing what’s right
72

Regulatory Affairs Associate Resume Examples & Samples

  • *Please note, this is a 1 year contract***
  • Degree in a pharmaceutical or life science / science
  • Direct experience working within regulatory affairs for NHP, OTC, DIN, medicinal products and/or devices or cosmetics, a minimum of 1-2 years
  • Awareness of regulatory processes in Canada
  • Experience of working flexibly across a portfolio of products
  • Knowledge of eCTD and related electronic submission processes
  • Demonstrated ability to review and approve regulatory documentation
  • Scientific background is required to enable an individual to work under the direct supervision of expert/manager with guidance (minimal autonomy)
73

Regulatory Affairs Associate Resume Examples & Samples

  • FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations
  • Pertinent Federal and State laws related to pharmaceutical regulatory affairs
  • Supervision and training practices and methods
  • Business, scientific and personal computer software applications
  • Business English usage such as, spelling, grammar and punctuation
  • Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods
  • Company policies, practices and procedures, including safety rules and regulations
  • Principles and practices of budget preparation and administration
74

Regulatory Affairs Associate Resume Examples & Samples

  • Execute global regulatory labeling strategies and plans for multiple complex projects including new products and ongoing compliance for products already on market. Understand and incorporate key labeling requirements and best practices into global labeling strategies
  • Help drive global UDI initiatives as well as global labeling traceability requirements within project and product teams
  • Represent the RA labeling function on assigned cross-functional project teams and projects. Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team
  • Monitor applicable global regulatory and labeling requirements; assure compliance with Baxter and external standards and help drive implementation across functions and projects
  • Help assess impact of emerging global labeling regulations and requirements and help implement appropriate changes. Support development of company policy and positions on draft regulation and guidance
  • Effectively perform gap analysis across multiple products and projects- including high volume tasks requiring global consistency. Support and document sound regulatory decisions and justifications
  • Establish appropriate cross-functional partnerships within RA and other functions to drive key global labeling strategies and initiatives
  • Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
  • Demonstrated interpersonal skills including strong negotiation and facilitation skills
75

Regulatory Affairs Associate Resume Examples & Samples

  • Applications for approval of new pharmaceuticals to Norwegian Medicines Agencies (NOMA) as well as submissions to NOMA for approval of changes or renewals of products on the market
  • Updates of prescribing information to physicians and information to patients
  • Align labelling materials to harmonize with authority approvals
  • Review and approval of our promotion material
  • Being an active partner in cross-functional teams
76

Regulatory Affairs Associate Resume Examples & Samples

  • Represents Regulatory Affairs on cross-functional project teams to support planning, development, implementation and execution of marketing strategies and ensures alignment with project business goals relating to combination product chemistry, manufacturing and controls (CMC) as well as product labeling issues on a local and global basis
  • Collect documentation for Annual Product Reviews
  • Degree in Pharmacy, Live Science, Chemistry or Medicine
  • Experience working in Regulatory Affairs function in Healthcare, Pharmaceutical
  • Clear understanding of HC regulations in Russia, basic knowledge about CIS is a plus
  • Result-oriented, though paying appropriate attention to the details, without derogating the ability to see the bigger picture
  • Good time management and self-discipline, sharp adherence to the deadlines
  • Ability to communicate scientific information. Strong interpersonal and communication skills
  • Fluent English language skills
77

Senior Regulatory Affairs Associate Resume Examples & Samples

  • Plans, coordinates and writes responses to inquiries from the FDA resulting from their review of the submissions. Submissions will include: ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) files
  • Reviews technical documents for accuracy and acceptability
  • Independently authors, complies and reviews ANDAs, NDAs, Amendments, Supplements and Annual Reports
  • Reviews and signs-off on change control documentation
  • Translates and communicates regulatory requirements and strategies to team members and to internal/external business units
78

Regulatory Affairs Associate Resume Examples & Samples

  • Develop and maintain GTS training and procedures
  • Conduct training for in- country and BU RA teams on GTS as needed
  • Maintain and ensure data integrity and completeness in GTS
  • Develop and conduct periodic audit plans to ensure quality data
  • Coordinate with regional and in-country RA teams to identify training needs
  • Identify training needs, and optimize business process
  • Follows Zimmer Biomet RA policies and procedures
  • Miscellaneous responsibilities as assigned
  • Strong writing, communication, and interpersonal skills
  • Ability to work with rapid changes; flexible and able to balance competing priorities
  • Ability to learn and apply regulations pertinent to medical devices, biologics, drugs and combination products, specific to functional work team
  • Self-motivated and capable to work in a diverse, fast-paced and dynamic environment
  • Ability to build strong relationships; communicate effectively at all levels
  • Basic computer skills, including Microsoft Office Suite
  • Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field preferred
  • Limited regulatory submission preparation experience a plus
79

Senior Regulatory Affairs Associate Resume Examples & Samples

  • Degree level education in a life science subject
  • Detailed knowledge of the regulations and guidance for global markets including, but not limited to, EU, FDA, Canada, Australia, Japan, and other distributed markets
  • Understanding of Quality Management Systems - FDA QSR, ISO 13485
  • Detail oriented and excellent written and verbal communication skills
  • Experience with medical device systems
  • Minimum 4 year experience in medical device regulatory affairs
80

Regulatory Affairs Associate Resume Examples & Samples

  • Provide regulatory affairs post-market support for company devices as well as assist with new product submissions
  • Preparation, maintenance and provision of Material and Device Master Files
  • Assist with Regulatory documentation preparation, compilation, submission and filing as required with applicable Regulatory bodies (both domestic and international) for product registrations
  • Respond to requests for Regulatory supporting documentation (i.e, CFG’s, ISO certificates, etc.)
  • Submit annual site registrations (i.e., FDA Establishment Registration/Device Listing(s), Health Canada MDL updates, etc.)
  • Ensures appropriate maintenance of regulatory documentation
  • Assists the Regulatory Affairs team with the creation, modification/update, and/or implementation of Regulatory Affairs policies, programs, and procedures as necessary
  • Other tasks and projects as assigned
81

Project Manager Regulatory Affairs Associate Director Resume Examples & Samples

  • May act as a Project Manager for a large stand-alone program, involving several regulatory or technical deliverables and/or region, and/or operation. Undertakes risk analysis, management and contingency plans, as appropriate
  • Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate
  • May manage meetings with Regulatory Agencies
  • May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients
  • Provides mentorship to junior colleagues and advise others on many regulatory document types
  • May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications
  • May be assigned as Reviewer and/or Approver for Regulatory SOPs or cross-functional SOPs owned by other operations
  • May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative
  • Performs other tasks or assignments, as delegated by Regulatory management
  • Extensive experience in regulatory and/or technical writing
  • Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers
  • Acts as a role model to junior colleagues; possesses a positive attitude and communication style to customers and colleagues. Communicates effectively with all levels of the organization and remains motivated and enthusiastic in times of change and other pressure situations
  • Ability to exercise independent judgement taking calculated risks when making decisions
82

Regulatory Affairs Associate Resume Examples & Samples

  • AS or BS degree, preferably in a scientific or legal discipline
  • Prior professional work experience in a regulated product industry or legal or governmental office; relevant internship experience will be considered
  • Excellent oral, written, and organizational skills required
  • Attention to detail is particularly important
  • Must be able to work as part of a team in a collaborative and constructive manner
  • Strong computer skills required; must be proficient in MS Office applications. Knowledge of SAP preferred
  • Ability to multi-task and prioritize multiple projects and work effectively with regulators, customers and co-workers
  • Ability to work in a constant state of alertness and safe manner
83

Regulatory Affairs Associate Resume Examples & Samples

  • Review of formulation (ingredients, nutrient levels) and other technical data associated with new product formulations to ensure in line with current legislation
  • Provide advice on suitability of formulations for Israel market
  • Representation of Regulatory Affairs in cross functional New Process Introduction Teams
  • Develop new (and maintain existing) product labels and datasheets in line with current legislation
  • Liaison with manufacturing sites, corporate head-office and affiliate departments on regulatory issues
  • Liaison with external regulatory authorities as required
  • Review new legislation and identify implications for Abbott Nutrition products
  • Provide technical support to Commercial Division as ne