Manager Regulatory Affairs Job Description

Manager Regulatory Affairs Job Description

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Manager regulatory affairs provides regulatory support in the development, revision, review, and approval of labeling content for submission to FDA, as well as any post marketing labeling changes.

Manager Regulatory Affairs Duties & Responsibilities

To write an effective manager regulatory affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included manager regulatory affairs job description templates that you can modify and use.

Sample responsibilities for this position include:

Manage the development and maintenance of Regulatory Operations systems, processes, checklists and procedures to facilitate consistency
Manage and review of labeling and promotional materials for submission to the Regulatory Agency
Engages in other labeling-related responsibilities (logistics, review and approval, local implementation )
Monitoring of legislative environment in main markets, EU, US, CAN and AUS and define and maintain an overview of the regulatory requirements and changes in the areas if applicable
Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements
Manage yearly Establishment Registration and Product Listings with FDA and Annual Reporting to Health Canada
Interprets regulations and provides regulatory guidance to cross functional development team
Assure compliance with U.S. and international regulations
Responsible for monitoring, interpreting, and implementing current and new regulatory requirements for the U.S. , EU and other jurisdictions, as appropriate
Manages the regulatory review of labels, labeling, and promotional materials

Manager Regulatory Affairs Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Manager Regulatory Affairs

List any licenses or certifications required by the position: RAC, MDD, US, RAPS, MDR, FDA, CE, FTA, GMP, ETL

Education for Manager Regulatory Affairs

Typically a job would require a certain level of education.

Employers hiring for the manager regulatory affairs job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Engineering, Chemistry, Pharmacy, Biology, Technical, Education, Life Sciences, Medical, Life Science

Skills for Manager Regulatory Affairs

Desired skills for manager regulatory affairs include:

Regulations
Operations
Commercialization
Regulatory requirements
FDA
Labeling
Clinical development
Domestic and international laws
Labeling negotiations
Marketing authorization

Desired experience for manager regulatory affairs includes:

Planning, coordination, organization and preparation of complete high quality regulatory submissions for assigned products, including both pre-approval and post-marketing submissions
Ensuring regulatory compliance for all assigned responsibilities
Implementation of regulatory strategies for the development and maintenance of assigned product or products
Preparing, compiling, and reviewing quality control and processing regulatory submissions
Attending and participating in assigned project/regulatory product development and submission teams, providing clear and consistent regulatory recommendations
Coordinating and consulting with other departments on the content, quality and assembly of regulatory documentation

Manager Regulatory Affairs Examples

1

Manager Regulatory Affairs Job Description

Job Description Example
Our company is growing rapidly and is hiring for a manager regulatory affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for manager regulatory affairs
  • Review new Retail and Corporate products proposals from compliance perspective against local regulatory requirements
  • Identify business impact for new regulatory requirements and escalate upwards as necessary
  • Participate in the new product initiative process by reviewing new product proposals for compliance against local regulatory requirements and providing the Head of RAM with a report on these requirements
  • People management, including hiring, coaching, training, development, performance review and management
  • Represents Regulatory Affairs to company senior management
  • Ensures implementation of standardization/new systems and processes to ensure efficiency and to support business continuity, including management of incoming and outgoing correspondence and archiving
  • Obtains input from Marketing and Medical Affairs to formulate local label strategy ( , content, sequence of indications)
  • Submits and obtains HA approval for initial and updated versions of local PI /Standard Export Package Insert (SEPI) as derived from CCDS
  • Tracks submissions and approvals (version controlled)
  • Develop and maintain strong relationships with staff in other departments, while monitoring and reporting on issues relevant to their work
Qualifications for manager regulatory affairs
  • This position will be located in Irvine, CA and may require travel both domestic and international
  • Experience with electronic document management software
  • Extensive Regulatory Affairs experience (5+ years) at both operational and strategic level (Head)
  • Hands-on experience in pharmaceutical product registration (Head)
  • Experience in Health Authority interactions
  • Understanding of commercial business ( Head)
2

Manager Regulatory Affairs Job Description

Job Description Example
Our company is growing rapidly and is hiring for a manager regulatory affairs. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for manager regulatory affairs
  • Planning and managing local regulatory submissions in compliance with corporate standards and local regulatory requirements
  • Keeps informed of global regulatory information
  • Participate in the development and implementation of regulatory strategy
  • Manages, coordinates and reviews regulatory submission documents and development activities to support regulatory filings
  • Lead and manage the preparation of meeting materials and responses to questions from health authorities
  • Compile and maintain regulatory database of regulatory information and submissions
  • Supports management with development and implementation of departmental strategies and policies
  • Independently research, prepare, and present on global regulatory topics to internal and external stakeholders
  • Monitor industry and regulatory trends and provide guidance related to such trends
  • Support global and regional trade compliance programs and processes (eg
Qualifications for manager regulatory affairs
  • Bachelor or equivalent in biological sciences, life sciences or related discipline with the required skills, knowledge and abilities that are typically acquired through extensive experience in the in vitro diagnostics, medical device or pharmaceutical industries
  • Demonstrated advanced software skills including Microsoft Word, excel, database
  • Degree in Veterinary Medicine (DVM or equivalent professional title) or equivalent degree in Animal Health related field
  • Knowledge of Russian is a plus
  • Excellent communicator (oral and written) in English
  • BS in a health, science or related field with 7 or more years of applicable US Drug Regulatory Affairs experience
3

Manager Regulatory Affairs Job Description

Job Description Example
Our growing company is looking for a manager regulatory affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for manager regulatory affairs
  • Be responsible for managing interpretation and dissemination of state and federal regulatory requirements
  • Develops and delivers training and educates internal and external audiences regarding federal and state legal and regulatory requirements
  • May prepare a single service regulatory or technical proposal for senior review and/or propose budgets for less routine projects, out of scope activities and potential budget efficiencies
  • Achieve the Regulatory Affairs coverage plan as contracted with the Head of Regulatory Affairs
  • Ensure that the business addresses concerns raised by the Regulator /delivers on commitments made to the Regulator
  • Implement and comply with BIA Audit recommendations pertaining to Compliance
  • Follow up on any compliance related findings or action items
  • Facilitate the Regulatory Change process in the business
  • Advise the business on any changes in set standards/ local requirements (throughout the year)
  • Act as a point of contact between the business and the regulators
Qualifications for manager regulatory affairs
  • Bachelor’s degree, preferably in a scientific discipline English • At least 7-10 years regulatory CMC experience for BS
  • Work cross functionally with research, clinical, quality, manufacturing, marketing, commercial, and product management
  • Must have experience communicating with EU/US Regulatory bodies
  • Knowledge of pharmaceutical basics
  • Eager to learn, independent, result oriented and persistent
  • Over 7 years professional experience in the area of Regulatory Affairs, Trade Compliance, Product Safety Product Stewardship, Marketing authorizations
4

Manager Regulatory Affairs Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of manager regulatory affairs. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for manager regulatory affairs
  • Ensure implementation of Compliance policies ‘controls within FLOD Conduct Risk Manual
  • Site regulatory support – develop regulatory procedures, corporate and external audits, authority inspections, labels and docs review and approval
  • Be responsible for product registrations and regulatory inspections/3rd party audits
  • Build rapport with regulatory authorities, RA counterparts within LT and external partners
  • Post market surveillance, reporting adverse events/recalls to the Authority
  • Manage performance of regulatory department
  • Monitors and influences assessment process to expedite and optimise the outcome of their submissions
  • Be responsible for managing various aspects of regulatory consulting for commercial health plan business
  • Oversee Qualified Health Plan and Affordable Care Act § 1557 non-discrimination compliance functions
  • Act as key point of contact with CMS regarding PHP federal exchange participation
Qualifications for manager regulatory affairs
  • Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions/dossiers [e.g., 510(k), pre-Submission, IDE, PMA, EU Technical Files
  • Ability to attract, recruit, mentor, and retain high-caliber professionals
  • RAPS RAC (U.S. ) preferred
  • Scientific bachelor degree in Pharmacy/ Chemistry/ Biochemistry/ or relevant field
  • 3-5 Years in Regulatory Field
  • Support all aspects of obtaining and maintaining registrations
5

Manager Regulatory Affairs Job Description

Job Description Example
Our company is growing rapidly and is hiring for a manager regulatory affairs. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manager regulatory affairs
  • Responsible for overseeing the conduct of quality assurance audits of RI trials and ensuring compliance with study protocols, program SOPs, policies, GCP and FDA regulations
  • Based on business priorities & capabilities, the Regulatory Specialist will provide support for licensing, approbations, registrations (new & renewals), CTDs, PIFs, Technical Files, regulatory administration, labeling (under supervision), and other assigned projects
  • Audits current data systems to assure integrity of the system (timeliness of data entry, accuracy, reliability, and validity of the clinical research data, adherence to regulatory requirements)
  • Prepares and submits regulatory documentation including IND/IDE applications, annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the U.S. Food and Drug Administration (FDA)
  • Leading Regulatory Affairs Council meeting to ensure the council members are apprised of new and upcoming regulatory requirements, and be a liaison for collecting information from BIUs to support Quarterly management reviews or any other metrics requested by Management
  • Develop and deliver training within RA and PV &
  • Undertake a variety of administrative duties to support the Centre
  • Instruct and guide other employees across the University within RA and PV &
  • Ensure that work is undertaken and documented in a regulatory compliant way and be prepared for regular audits and inspections, contributing to the development of the Quality management system for the area of RA and PV &
  • Maintain liaison with raw material vendors, container/closure manufacturers, and distributors
Qualifications for manager regulatory affairs
  • Develop and implement training and enhancement of policies and standards within the N&H regulatory framework
  • Monitor international best practice, including global benchmarking of the regulatory environment and regulatory affairs functions
  • Create effective communication channels for the regulatory strategy and framework across the N&H businesses
  • Monitor and advocate Codex position in Codex Asia, Codex country committee consistent with business needs based on science and global position
  • Work collaboratively with regulatory and business leads of specific portfolios to map regulatory pathways and communicate clearly on timeline to advocate right through approvals and support needed to business partners
  • Honesty in defining gaps and failures, and find solutions to improve and/or find solutions to achieve business goals

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