Title: Senior Manager, Regulatory Affairs Advertising and Promotions
Company Summary
One of the best/award-winning Southern California biotech's is looking to bring on a key Regulatory Affairs Advertising and Promotions hire to contribute to the development of Regulatory Strategy and preparation of Regulatory Submissions. In addition to the organization's 2 commercialized products, you can look forward to the many late-stage indications to follow the same path of success. An organization of this pedigree will not only allow for the mentorship from truly talented professionals, but the career development of a lifetime.
Overview
We are looking for a detail-oriented and personable Regulatory Affairs Advertising and Promotions Senior Manager who has a working knowledge of both US and Global commercial regulations. This position will require collaborations with cross-functional professionals and execution of promotional campaigns. You will be responsible to contribute to the writing and development of commercial regulatory strategy and represent the organization to health authorities.
Responsibilities
- Contribute to the review and development of commercial strategies
- Implement the organization's advertising and promotions strategies in alignment with US and global regulations and guidelines
- Represent Regulatory Affairs on the Medical Review Committee (MRC)
- Review medical education materials for products and training programs
- Lead the Promotional Review Committee (PRC)
- Develop essential timelines for all tasks
- Report to the Director of Regulatory Affairs Advertising and Promotions
- Work cross-functionally in collaboration with marketing, etc. teams
- Participate as a core member of the Regulatory Affairs Advertising and Promotions team
- Work hands-on in a dynamic fast-paced environment
Experience and Qualifications
- Minimum of 5+ years direct related professional experience with a minimum of 2+ years within Regulatory Affairs Advertising and Promotion
- Experience with electronic document management systems (Veeva Vault, Microsoft, Adobe Professional, etc.)
- Proven track record and experience with advertising and promotions review in alignment with regulations and guidelines
- Significant knowledge and understanding of FDA guidelines
- Ability to work independently and take direction from a mentor
- Interpret Regulatory Affairs documents, submissions, and reports
- Excellent verbal and written communication skills
Education
- Minimum of bachelor's degree or above in a life sciences field from an accredited college or university required.
- An advanced degree preferred
If you are interested in the Senior Manager of Regulatory Affairs Adverting and Promotions role, do not hesitate to apply!
