Regulatory Affairs Manager – PMA – FILLED
The Wellington Group has been retained to find a seasoned Regulatory Affairs Manager – PMA. Ideal candidate has extensive experience with Pharmaceutical Promotional Materials, Review and Approval experience for a growing biotech company with a focus on current and future pharmaceutical and biological technologies.
The Regulatory Affairs Manager will provide regulatory support of promotional materials and practices and preparation of submissions for new product registrations. The manager will be required to review, approve and monitor product advertising and promotional materials. The manager will also provide input on Medical Affairs and Corporate Communications practices to ensure compliance with applicable laws and regulations, industry best practices and the company’s procedures.
Responsibilities of the Regulatory Affairs Manager – PMA include:
- Maintaining thorough knowledge of current rules and regulations governing advertisement and promotions, new product registration as well as recent FDA enforcement actions and communication trends
- Developing, implementing and maintaining internal policies and procedures for appropriate review, approval and finalization of all ad/promo materials, promotional activities and product labeling
- Developing and leading training for relevant internal staff on ad / promotional policies, procedures and best practices
- Preparation and management of submissions in support of new product registrations including new INDs, IND Amendments and Annual Reports, new BLAs, MAAs, DINs
- Submission of advertising and promotional pieces to regulatory authorities
- Preparation and management of submissions in support of new product registrations
The qualified Regulatory Affairs Manager – PMA candidate will have:
- Bachelor degree
- 5 years of experience with FDA, CBER, CDER and/or USDA is preferred
- 3 years direct experience with review, approval and finalization of all ad / promotional materials
- Demonstrated knowledge of Regulatory Affairs within the pharmaceutical industry
- Detail oriented and must be a strategic problem solver
- Effective written and verbal communication skills
- Ability to work cross functionally among other departments to uphold a team environment
Industry: Pharmaceuticals, Biologics, Advertising, Promotional Material, Registration, Regulatory Affairs, DDMAC, PDMA
Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.