Associate Director Regulatory Advertising & Promotions
My client is a world-wide bio-pharmaceutical company who is redefining their business model related to new drug technologies and specialties. With several successful years of approvals under their belt and a multi-billion dollar revenue stream, they have a solid foundation of stability built on over several decades of doing business within life sciences. They anticipate growing 50% in the next year and are looking for an Associate Director of Regulatory Advertising and Promotions to help in managing promotional review activities with a wide array of therapeutic programs. You should be science driven, collaborative and not afraid to roll up your sleeves while working in a newly developed specialty pharmaceutical division.
Responsibilities:
- Provide regulatory leadership and guidance to the marketing team during the development, review and approval of product labeling and advertising materials
- Assist the Head of Regulatory Services in regulatory oversight related to advertising and promotional activities within company
- Work directly with each of the marketing teams from concept through review and approval, up to and including DDMAC/OPDP submissions
- Represent the company to outside customers and agencies and make presentations as needed on current regulatory issues pertaining to Advertising and Promotional activities
- Provide oversight of regulatory document control activities.
- Work collaboratively with medical and scientific personnel on development and review of materials related to advertising and promotion
Knowledge and Skills:
- Minimum BS/BA in scientific discipline, PharmD/PhD preferred
- Minimum 7 years Regulatory Affairs experience with 3-4 years of labeling experience
- Must have promotional review interaction experience (OPDP, DDMAC)
- Must be able to work within all levels of management
- RAC certification a plus
- Drug/device experience a plus