Regulatory Scientist Resume Samples

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BV
B Vandervort
Breana
Vandervort
47760 Elroy Heights
Detroit
MI
+1 (555) 678 5992
47760 Elroy Heights
Detroit
MI
Phone
p +1 (555) 678 5992
Experience Experience
Phoenix, AZ
Regulatory Scientist
Phoenix, AZ
Kling, Watsica and Vandervort
Phoenix, AZ
Regulatory Scientist
  • Manage technical product documents, including retrieval, review, modification, and storage
  • Provide international regulatory support for new market openings
  • Collaborate with cross functionally and with suppliers to obtain accurate regulatory documents in a timely manner
  • Leverage knowledge of key processes and stakeholders to navigate the organization effectively and achieve results
  • Address regulatory import/export issues and collaborate cross-functionally to develop solutions that meet business objectives and ensure compliance
  • Lead conference calls with regional and/or in-market contacts to support international product registrations, receive and provide regulatory updates, and align on best practice
  • Request, review, approve, disseminate, and/or store technical information
Chicago, IL
R&D Regulatory Scientist
Chicago, IL
Cassin-Haley
Chicago, IL
R&D Regulatory Scientist
  • Providing regulatory guidance to RD&Q, PCMs, Marketing, Consumer services
  • Artwork Approval
  • Providing technical information on products to answer enquiries from local Authorities
  • Coordination and Information of the regulatory network
  • Supporting managers
  • LABEL spec generation, PROD spec review including H&W policies, Master Artwork Review
  • Priority Setting
present
Los Angeles, CA
Senior Reach Regulatory Scientist
Los Angeles, CA
Moen Inc
present
Los Angeles, CA
Senior Reach Regulatory Scientist
present
  • Growing and driving the business forward and securing new projects, identifying and developing new business opportunities for the company
  • Providing regulatory strategy and advice relating to the EU REACH scheme
  • Acting as the primary client contact and ensuring that registrations are delivered to a high standard, on time, and within agreed budget
  • Managing complex REACH projects and providing high level technical and regulatory consultancy services to industrial chemical clients
  • Mentoring and managing members of the industrial chemicals team
  • Keeping up to date with developments in the field of chemical regulations, particularly with regard to REACH and worldwide industrial chemical notification schemes
  • Promoting Exponent’s services, particularly in the fields of REACH and new chemical notifications
Education Education
Bachelor’s Degree in Food Science
Bachelor’s Degree in Food Science
Webster University
Bachelor’s Degree in Food Science
Skills Skills
  • Ability to assimilate new information quickly and react positively to new and challenging opportunities
  • Excellent verbal and written communication skills and will be capable of simplifying complicated technical subjects to present to non-technical audiences
  • Ability to multitask, maintain attention to detail and remain calm under pressure
  • Ability to manage multiple priorities and deliver accurate outcomes
  • Ability to identify gaps and drive improvements
  • Ability to communicate technical information to non-technical partners in a clear and concise way
  • Spanish speaker highly recommended
  • Ability to navigate through ambiguous and unstructured situations
  • Ability to communicate effectively and influence internal and external stakeholders
  • Ability to build relationships with key stakeholders
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15 Regulatory Scientist resume templates

1

Regulatory Scientist Resume Examples & Samples

  • Manage technical product documents, including retrieval, review, modification, and storage
  • Provide international regulatory support for new market openings
  • Collaborate with cross functionally and with suppliers to obtain accurate regulatory documents in a timely manner
  • Leverage knowledge of key processes and stakeholders to navigate the organization effectively and achieve results
  • Address regulatory import/export issues and collaborate cross-functionally to develop solutions that meet business objectives and ensure compliance
  • Lead conference calls with regional and/or in-market contacts to support international product registrations, receive and provide regulatory updates, and align on best practice
  • Request, review, approve, disseminate, and/or store technical information
  • Build regulatory expertise
  • Inform internal team members of regulatory changes, and begin developing as a subject matter expertise
  • Collecting, reviewing, and managing technical product information: (1-3 years)
  • Researching international food and beverage regulations and registering products in foreign markets: (1-3 years)
  • Consulting cross-functional team members on regulatory requirements: (1-3 years)
  • Familiarity with product development, creative, and commercialization processes for a food and beverage company: (1-3 years)
  • Spanish speaker highly recommended
  • Bachelor’s degree in Food Science, Nutrition, or related field
  • Computer proficient, savvy with MS Excel and Outlook
  • Ability to handle large volumes of technical data in an organized manner, analyze it, and recommend solutions
  • Ability to build relationships with key stakeholders
  • Ability to identify gaps and drive improvements
  • Ability to communicate technical information to non-technical partners in a clear and concise way
  • Ability to assimilate new information quickly and react positively to new and challenging opportunities
  • Ability to navigate through ambiguous and unstructured situations
  • Ability to communicate effectively and influence internal and external stakeholders
  • Ability to manage multiple priorities and deliver accurate outcomes
  • Ability to multitask, maintain attention to detail and remain calm under pressure
2

Regulatory Scientist Resume Examples & Samples

  • Collaborate with suppliers/partners to obtain accurate regulatory documents in a timely manner
  • Address regulatory issues and collaborate cross-functionally to develop solutions that meet business objectives and ensure compliance
  • Lead conference calls with regional and/or in-market regulatory contacts to support international product registrations, receive and provide regulatory updates, and align on best practice
  • Inform internal team members of changes, and begin developing as a subject matter expertise
  • Years of experience: (0-3 years minimum)
  • Collecting, reviewing, and managing technical product information: (0-3 years)
  • Researching international food and beverage regulations and registering products in foreign markets: (0-3 years)
  • Consulting cross-functional team members on regulatory requirements: (0-3 years)
  • Bachelor’s degree in Food Science, Nutrition, International Business or related field
3

Regulatory Scientist Resume Examples & Samples

  • Experience with qualitative and quantitative safety and efficacy data sets
  • Knowledge of regulatory health
  • Knowledge of FDA regulatory requirements
  • 5+ years of experience with project management
  • 5+ years of experience with business development in the government, biotechnology, pharmaceutical, or life science sectors
  • Experience with product surveillance and safety pharmacovigilance
  • Experience with consulting
  • Knowledge of CDISC data standards
  • BS degree in a life sciences field
  • Regulatory Affairs Certification (RAC)
4

Reach Regulatory Scientist Resume Examples & Samples

  • Managing and assisting in the completion of complex REACH projects
  • Providing technical and regulatory consultancy services to industrial chemical clients
  • Assessing our client’s obligations under the REACH legislation and development of appropriate regulatory strategies to enable them to meet these requirements
  • Contributing to the generation of technical documents required for REACH registrations, as well as being responsible for successful completion of projects
  • Advising on regulatory strategy and the EU REACH scheme
  • Keeping up to date with developments in the field of chemical regulations, particularly with regard to REACH and worldwide industrial chemical notification schemes
  • BSc degree or above in Biology, Chemistry or another related scientific field
  • Ability to work independently and also with a team
  • Excellent communication skills and used to working under pressure and deadlines
  • Proven experience of data interpretation
  • Ability to demonstrate sound judgement and decision-making
5

Senior Reach Regulatory Scientist Resume Examples & Samples

  • Providing regulatory strategy and advice relating to the EU REACH scheme
  • Managing complex REACH projects and providing high level technical and regulatory consultancy services to industrial chemical clients
  • Growing and driving the business forward and securing new projects, identifying and developing new business opportunities for the company
  • Acting as the primary client contact and ensuring that registrations are delivered to a high standard, on time, and within agreed budget
  • Promoting Exponent’s services, particularly in the fields of REACH and new chemical notifications
  • Mentoring and managing members of the industrial chemicals team
6

Regulatory Scientist Resume Examples & Samples

  • Managing and tracking client projects, project deliverables and budgets
  • Interacting with internal project staff to discuss client projects, tasks, deliverables and budgets
  • Editing and proofreading complex regulatory and technical reports
  • Providing regulatory and technical review and quality control support for FIFRA and related projects
  • Reviewing literature and regulatory guidance documents as it relates to projects
  • Synthesizing technical and regulatory information
  • Monitoring and processing invoices related to project work and studies
  • Interacting with clients
  • Coordinating with laboratories related to project work
  • Organizing and assisting with the daily activities of the practice
  • Preparing client presentations
  • Performing literature and internet research as related to project work
  • Bachelor or Master’s degree in a Science or related field
  • Excellent communication, writing, editing and proofreading skills
  • Must be detail oriented, able to work independently, and manage time effectively
  • Strong ability to organize and prioritize multiple projects with competing deadlines
  • Excellent interpersonal skills and ability to work in a collaborative environment
  • Experience in a scientific and/or research environment a plus
  • Experience with project management, budget tracking, and invoicing a plus
  • Strong working knowledge of Access, Excel, Word, PowerPoint, Outlook, Adobe and Internet Explorer required, experience with MS Project a plus
  • Exposure to sensitive information will necessitate considerable use of tact, diplomacy, discretion, and judgment
7

CMC Regulatory Scientist Resume Examples & Samples

  • Bachelor’s Degree with 5-7+ years OR Master's with 3-5+ years with pharmaceutical industry experience in CMC technical drug development
  • Prior experience authoring CMC submission content is desirable
  • Biotechnology experience in biologics strongly preferred
  • Demonstrated strong written, spoken and presentation communication skills
  • Demonstrated negotiation and influence skills
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
8

Regulatory Scientist Resume Examples & Samples

  • Experience with conducting market and patent analysis in the oncology, virology, neuropsychology, drug delivery, and bioinformatics fields
  • Ability to evaluate biomedical technologies, including wearables and vaccines
  • Ability to design and execute collaborative cancer biology projects, as needed
9

Regulatory Scientist Resume Examples & Samples

  • Assure accurate, reliable and timely regulatory checks, specifications, documentation, internal approvals, label compliance and local approvals/product registrations (if requested) in the area of responsibility to enable implementation of business goals
  • According to business plans and strategies, execute SARA work for all Mondelēz International food categories in Nordic but mainly for chocolate and chocolate related brands for labelling and compliance check to enable implementation of growth, productivity and brand maintenance goals
  • Interact and communicate as a regulatory partner with multiple functions, work in close cooperation with product/ packaging development, marketing, supply chain, quality, country management and product change partners in our business units and plants
  • Create product labeling information including ingredient declarations, allergen information and nutrition labeling using Meridian specification system for Nordic market
  • Support Consumer relations teams with queries regarding all Mondelēz International products dedicated for Nordic market under guidance from management
  • Ensure position's alignment to Mondelēz International vision and values as its compliance to ISO 9001/14001 /18000/22000 quality, food safety, labour safety and security, environment, health and safety management systems‘ requirements, company QCMS, laws, standards, Mondelēz International privacy policy, data protection principles and Mondelēz Europe Services GmbH internal policies and procedures' requirements, other Mondelez polices regulations
  • Bachelor's or equivalent in Food Chemistry, Food Technology, Food Science or Nutrition or other relevant discipline
  • Reliable, accurate and attention to detail
  • Fluent in Norwegian (written & spoken)
  • Fluent in English (written & spoken)
  • Fluent in another language(s) (Nordic language)
  • Proactive team worker with organizational / project management skills
  • Working experience in Regulatory Affairs or a Quality function
  • Experienced in working in an international and multifunctional environment
10

Lead Regulatory Scientist Resume Examples & Samples

  • Represents UK Regulatory Affairs both externally and internally as UK affiliate to the Roche Development organisation and other Regulatory affiliates
  • Build contacts and understanding across the business, to optimise current and future Regulatory activities
  • Proactively seek knowledge in specialist areas, interpret and communicate impact analysis within Regulatory Affairs and across relevant business areas
  • Ensures high quality regulatory submissions are made in a timely manner in collaboration with colleagues to maintain licences compliantly. Ensure approved changes are implemented
  • Be able to find, understand and apply regulations and guidance relevant to our work
  • Provide specific guidance on regulatory issues to support internal customers
  • Act as primary regulatory product contact for assigned products cross functionally, interfacing with local medical and marketing teams and Headquarters Regulatory
  • Know the brand strategies. Timely communication of regulatory activities and timelines to support brand planning
  • Assess technical/scientific content of proposed national submissions to meet requirements. Propose solutions to correct deficiencies
  • Ensures questions and commitments from our national regulatory authorities (UK, Ireland, Malta) are proactively managed
  • Be able to coach less experienced colleagues in their work
  • Contribute to efficiency and process improvement, including development of best practices, SOP maintenance and appropriate tracking tools, templates
  • To ensure that personally and within the team: High ethical standards are maintained at all times, there is full compliance with all applicable laws, regulations, industry codes and internal policies and procedures
11

Regulatory Scientist Resume Examples & Samples

  • Support GRL to lead the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant UCB procedures and local country regulations
  • Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
  • Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL
  • Delivers project assignments supporting the business e.g. representation on functional workstreams
  • Assist in development of regulatory standards and SOPs
  • Flexibility and adaptability - Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person. Works effectively in ambiguous situations
  • Communication skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
  • Results focused – ability to overcome obstacles and achieve key outcomes
  • Analytical – logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
  • Organizational Skills with an a high level of attention to detail
  • Integrity – overriding commitment to integrity and high standards in self and others
  • Build effective partnerships – identifies opportunities and takes actions to build effective relationships within team and with other areas
  • Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions
12

Regulatory Scientist Intern Resume Examples & Samples

  • Search and review scientific literature and regulatory publications to summarize key insights on a given topic to help develop product regulatory strategy
  • Provide regulatory and scientific guidance to Cargill Food Ingredient business units
  • Develop and manage scientific substantiation and reports to support product claims and regulatory compliance
  • Review collateral marketing materials for accuracy of health benefit related statements and regulatory compliance
  • Currently pursuing a M.S., or Ph.D. in Food Science, Food Technology, Nutrition, Toxicology, Pharmacology, Chemistry or related science degree
  • Demonstrated organizational skills and attention to detail
  • Skilled in conducting relevant literature search, review and evaluation of scientific literature, and summarization of key findings
  • Moderate to advanced scientific knowledge: chemistry, acids &bases, solvents, biology/microbiology, food science
  • Strong interest in Regulatory career path post-graduation
  • Strong leadership and technical skills
  • Moderate computer skills (word processing, spreadsheets, and database navigation)
13

R&D Regulatory Scientist Resume Examples & Samples

  • Products Labelling Reports (PLRs) generation for local brands for the country of scope
  • Regulatory key contact in the EU project team
  • Coordination and Information of the regulatory network
  • Deviations pre-review (preparation of the consolidated regulatory assessment)
  • Preparing answers to consumer queries or to other internal/external people
  • Artwork Approval
  • Supporting managers
  • Support for cross-category/cross functional projects
  • Food Sciences University Degree
  • Food Industry experience
  • Flexibility
  • Fluent Englis both written and spoken
  • Fluent Czech is a must
14

R&D Regulatory Scientist Resume Examples & Samples

  • PLRs Translation
  • Simple Artwork Approval
  • Collecting data
  • Contributing to the training and introduction of newcomers
  • Bachelor/Master or equivalent in Food Chemistry, Food Technology, Food Science or Nutrition is a must
  • Experienced in Scientific & Regulatory Affairs, Quality, R&D will be an asset
  • Detailed oriented
  • Fluent in Lithuanian (written & spoken)
  • Russian fluency wil be additinal asset
15

Senior Regulatory Scientist Resume Examples & Samples

  • You will develop, implement and communicate regulatory science strategies and defend them to internal and external stakeholders
  • You will plan and conduct all agreed studies to investigate the metabolism in plants and animals with a strong focus on animal metabolism studies
  • You will also be responsible for other regulatory activities (e.g. dossiers, risk assessments) according to compliance, safety and financial requirements
  • You have successfully completed your studies in natural sciences (Master/Diploma/Ph.D.) or veterinary medicine
  • Besides your profound experience in project management, you are able to present results and lead discussions professionally
  • You are well acquainted with the standard IT applications and are versed in using your excellent English language skills on a daily basis at work
  • In addition to driving innovations and sustainable solutions, you also collaborate for achievements and communicate effectively
16

Reach Regulatory Scientist Resume Examples & Samples

  • BSc degree or above in Chemistry, Biology or Environmental field
  • Proven experience of clearly and concisely summarising scientific data
  • Experience of data interpretation
  • Must be able to work autonomously
  • Excellent written and verbal communication skills with attention to detail
  • Proficient in the use of Microsoft packages
  • Able to work under pressure to time constraints and deadlines
  • Self-motivated and organised
  • Experience using the IUCLID software package
  • Consultancy experience
17

Regulatory Scientist Resume Examples & Samples

  • Serve as a regulatory compliance subject matter expert for Stepan’s biocide business
  • Contribute to the submission and maintenance of Stepan’s pesticide registrations at the state and federal level. under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and related regulations
  • Monitor federal regulations related to Stepan’s pesticide products
  • Implement compliance-related activities on Stepan’s behalf with state and federal agencies; customers and internal compliance efforts
  • Familiarity with and ability to review and proofread pesticide product labels
  • Ability to act as a Regulatory Liaison to Stepan’s Business and Sales Divisions
  • Ability to build constructive relationships and interface with Stepan customers, as well as state and federal regulators
  • Represent Stepan at trade association conferences and industry meetings
  • Managing or directing the work of one or more project team members
  • Engages with project teams and contributes regulatory strategies and tactics on products of interest inside and outside the company
  • Bachelors Degree with technical background such as Chemistry or similar field with a minimum of 5-8 yrs exp
  • Advanced Degree preferred
  • Preferred knowledge of FIFRA regulations/standards
  • Experience preparing government submissions for biocide or antimicrobial pesticide product registrations at the state or federal level, conducting compliance audits, or manufacturing experience preferred
18

R&D Regulatory Scientist Resume Examples & Samples

  • PLR translation review and local approval for MEU brands sold in France and/or Benelux
  • Labelling coordinator role for a MEU brand
  • Fluent in French or Dutch (ideally both)
  • Good notions of Spanish will be an additional asset
19

Regulatory Scientist Resume Examples & Samples

  • University degree in Food Chemistry, Food Technology, Food Science or Nutrition
  • Experience in Scientific & Regulatory Affairs, Quality, R&D
  • Experience in food industry as an advantage
  • Fluent English (written & spoken); other European languages as a plus
20

Regulatory Scientist Resume Examples & Samples

  • Conducting consultancy work in the Biocides sector
  • Project Management of work programmes, including budget, communication, Quality Assurance, delivery
  • Preparation of technical reports and dossiers
  • Product support in a regulatory setting
  • Developing and implementing strategies for EU and global regulatory authorisations; provision of regulatory advice
  • Contributing to expansion of Biocides business
  • BSc degree or above in Biology, Chemistry or another related field
  • Proven experience of working in a Biocides Regulatory Environment
  • Strong networking and interpersonal skills
  • Forward looking, creative and a strategic thinker
  • Excellent presentation and communication skills​
21

Manager, Regulatory Scientist, Oncology Resume Examples & Samples

  • A Bachelor's degree in a scientific field and a minimum of 8 years of overall professional experience is required; OR an advanced degree (MS, PharmD, or PhD) and a minimum of 4 years of overall professional experience is required
  • Regulatory Affairs experience is strongly preferred
  • Understanding of the drug product lifecycle from discovery to marketing is required
  • Medical/scientific understanding of clinical trials is strongly preferred
  • Knowledge of HA organizational structure and HA processes for reviewing submissions is required
  • Experience with companion diagnostics, combination products and/or biomarker development is preferred
  • Strong knowledge of oncology disease area and landscape is preferred
  • Strong knowledge of FDA, ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required
  • Proven experience working within a collaborative team environment as an individual contributor and decision maker within a cross-functional organization is required
  • Proven experience effectively prioritizing assignments for multiple products and projects simultaneously is required
  • Limited travel (less than 10%) may be required
  • The preferred location for this position is Raritan, NJ, but can also be located in Spring House, PA
22

Regulatory Scientist Resume Examples & Samples

  • Interacting with other groups within Global Regulatory Affairs (GRA) and beyond, as needed, to manage and resolve cross-functional issues
  • Actively supporting Global Regulatory Leads (GRLs) as assigned
  • 1) Responsible for executing regulatory strategies that result in successful regulatory submissions, approvals and renewals for assigned products
  • 2) Responsible for the compilation of high quality regulatory documentation
  • 3) Leads or facilitates the development of core briefing documentation and supports regulatory agency meetings, regulatory advisory committee meetings, scientific conferences or equivalents
  • 4) The Regulatory Scientist assists in the development and review of local labeling in accordance with the Company Core Data Sheet (CCDS)
  • 5) In collaboration with cross-functional partners, develops and reviews post marketing periodic safety reports and contributes to the safety and efficacy risk assessment for assigned products, as required
  • 6) As needed, represents GRA DP at the GRA internal product strategy team, i.e. GRAST and at cross-functional teams with clinical and/or safety focus, i.e. Life Cycle Management (LCM) meetings
  • 7) Identifies relevant guidance documents, international standards and regulatory rule changes related to clinical/ safety product life-cycle management. Ensures appropriate communication within GRA and CSLB
  • 8) Assists with compliance activities (including appropriate electronic systems), to ensure consistency, completeness, and adherence to global regulatory standards for all regulatory submissions. This may include initiation, development, review and update of departmental procedural documents such as SOPs and Working Instructions
  • Preferably 2-3 years’ pharmaceutical industry experience. Regulatory (including CMC regulatory) experience is highly desirable
  • Knowledge of local regulatory requirements/guidelines in an ICH region (US, European Union, or Japan)
  • Knowledge of and understanding of post-approval regulatory maintenance processes
  • Knowledge of scientific and clinical research terminology
23

Regulatory Scientist Resume Examples & Samples

  • Preparing high-quality regulatory submission documents relating to dietary exposure and risk assessment of consumers of food crops treated with crop-protection chemicals, to include summaries of study reports, exposure and risk assessment calculations and overall conclusions
  • Developing knowledge and experience in the areas of crop and livestock metabolism, residues, processing and other study types
  • Sound judgement
  • Regulatory/authorisation procedures for crop-protection chemicals, biocides or industrial chemicals
  • Interpretation of data from scientific studies
24

Regulatory Scientist Resume Examples & Samples

  • Contribute to the submission and maintenance of Stepan’s pesticide registrations at the state and federal level under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and related regulations,
  • Review and proofread pesticide product labels
  • Act as a Regulatory Liaison to Stepan’s Business and Sales Divisions
  • Build constructive relationships and interface with Stepan customers, as well as state and federal regulators
  • Manage or direct the work of one or more project team members
  • Engage with project teams and contribute regulatory strategies and tactics on products of interest inside and outside the company
  • Bachelors Degree with technical background such as Chemistry or similar field
  • A minimum of 5-8 years experience
  • Knowledge of FIFRA regulations/standards preferred
25

Regulatory Scientist Resume Examples & Samples

  • Participate in global regulatory team meetings as appropriate
  • Advise the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
  • Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area
  • Act as back-up for contact with Regulatory Agencies as needed
  • Draft cover letters for Regulatory Agency communication
  • Assist in the preparation of meetings with Regulatory Agencies
  • Liaise with LOCs, and ensure responses to queries are made in a timely manner, and that content is consistent with the regulatory strategy
  • Assist in development and improvement of processes related to regulatory submissions
  • An advanced degree (MS, Pharm D, PhD) is highly preferred, a minimum of a Bachelor’s Degree is required
  • 1+ year relevant experience with an advanced degree OR 4+ years with a Bachelor’s Degree is required
  • Pharmaceutical industry experience
  • Understanding of the drug development process and regulatory submission and approval process
  • Knowledge of the regulatory environment, US guidelines and practices
  • Direct experience in regulatory affairs is desirable
26

Regulatory Scientist Cimzia Resume Examples & Samples

  • Support the Global Regulatory Leader (GRL) for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant UCB procedures and regional/local country regulations
  • Lead the planning, preparation and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective
  • Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
  • Identify potential regulatory risks to the operational plan, and propose options to mitigate risks
  • Maintain awareness of competitors’ activities and share potential impact these activities may have on the product development program
  • Ensure that appropriate, up-to-date records are maintained for compliance
  • Provide input into Regulatory Strategy Plans and project budget as delegated by GRL
  • Assist in due diligence activities for in-licensing opportunities
27

Regulatory Scientist Resume Examples & Samples

  • Preferably have a Masters or Ph.D degree in food toxicology, organic chemistry, analytical chemistry, polymer chemistry, biochemistry, biology, or related field
  • Post-graduate professional status/training related to toxicology (e.g. DABT), food science, packaging safety evaluation, risk assessment, or clinical sciences desirable
  • A minimum of 5-10 years of related work experience in a government, food industry, or food packaging industry role with an emphasis on Food Safety/Toxicology including an understanding of the properties, safety, effects, and detection of substances in foods and/or food packaging
  • Experience and/or training in the US and global regulation of food, pharmaceutical, and biomedical contact substances desirable
  • Proficiency in computer software such as Microsoft Word, Excel, and Power Point is required
  • Self directed and require minimal direction from management
  • Candidates should be able to exercise appropriate judgment to make decisions that support strategic company objectives
  • Organized and accurate in work
  • Excellent verbal and written communication skills and will be capable of simplifying complicated technical subjects to present to non-technical audiences
  • Candidate should also be able to effectively interact with all levels of associates (from production floor to senior management)
  • Provide regulatory and scientific support to the Regulatory staff and other internal business partners to support existing product lines, changes, and innovation projects in support of the company’s strategic initiatives. Work closely, particularly with R&D, to ensure product compliance in development
  • Establish appropriate material testing protocols as needed to assess existing and new materials and products (typically migration testing). Review and interpret associated testing results
  • Communicate and interact with parties external to Printpack such as customers, suppliers, industry groups, and regulatory agencies as necessary to perform the functions of the role
  • Represent Printpack on scientific committees and in various industry and technical organizations related to food packaging regulatory compliance and report back on activities
  • Serve as the company subject matter expert for packaging related chemical substances, toxicology, food packaging migration studies, and risk assessments
  • Monitor and stay current on emerging issues related to food packaging safety, chemistry, toxicological information, and regulations for food, pet, and medical packaging. Complete analyses on the potential impact of these areas to Printpack’s business and communicate and collaborate internally on these topics
  • Participate in maintaining and development of Printpack’s regulatory policies, guidelines, and procedures. Assist with design, implementation, and monitoring of systems and programs to ensure food safety and regulatory compliance of Printpack’s products based on scientific methodology
28

Senior Regulatory Scientist, G&C Resume Examples & Samples

  • Manages/lead regulatory input on project teams for large to major-sized projects, including those with multiple business partners. Project scope could involve several sub-projects. Works with the Category Regulatory lead for G&C MEU to allocate projects across the G&C Regulatory team
  • Independently conducts relevant legal compliance checks (ingredients, recipes, specifications, claims) and nutritional profiling and prepares appropriate documentation including labelling data and artwork approvals in an accurate, reliable and timely manner to support product launches. This work will encompass European and local projects as required to support the G&C category
  • Issues PLRs & Local implementation
  • Artwork Approval
  • Ensures consistency, technical precision and compliance with methods of work. Identifies new opportunities or improvements in programs within department
  • Effectively structures and presents status updates / proposals to influence partners or share with higher management (up to and including Director-level). Interfaces independently with Senior Management and external partners
  • Has an established network with business partners within and across categories, with particular emphasis on building proactive relationships with colleagues in MEU, EMEA & Global G&C Category to ensure early regulatory involvement in all relevant activities
  • Builds expertise in one or more specialised areas of Regulatory Affairs to enable them to be seen as a leader in this area within the KFE SARA community. Trains others within department on range of topics within own scientific discipline
  • University Degree or equivalent in Food Chemistry, Food Technology, Food Science or Nutrition
  • Good Knowledge in EU food regulations and at least 1 Member State
  • Experience of practical application of food regulations in a commercial environment or trade association
  • Deep product, technology and quality understanding
  • Excellent knowledge of internal requirements, policies and guidelines
  • Familiar with quality systems, processes including specifications management systems
  • Excellent cross-functional and external organizational skills, including time management and priority setting
  • Ability to work independently and solve problems independently
  • Strong project management skills (including project plans, updates, flagging derailers on time, etc.)
  • Fluency in English. Fluent in other EU language (French, German, Dutch) as a plus