Proclinical is seeking a hybrid Associate Director, Global Regulatory Affairs, Advertising & Promotion for a large global pharmaceutical company located in Bridgewater, NJ and Cambridge, MA.
In this role, you will serve as the regulatory lead on Promotional Review Committees. As the PRC Regulatory Affairs representative, you will work with brand on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the advertising and promotion of prescription drugs, biologics, and devices.
The position will be based at either their New Jersey or Massachusetts site in a hybrid work schedule.
Must be eligible to work in the US.
Job Responsibilities:
- Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials.
- Work directly with Commercial teams from concept through review and approval, up to and including APLB submission.
- Provide a leadership role on the promotional review committee by providing regulatory guidance on promotional labeling and advertising materials.
- Develops solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating and managing business risks.
- Serve as FDA liaison for matters related to the advertising and promotion of assigned products.
Skills and Requirements:
- At least five (5) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry.
- Extensive experience providing regulatory input and evaluation as part of a promotional review committee.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at +(1) 646-779-7961 or p.huynh@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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