Director, Regulatory Affairs, Advertising and Promotion

2 weeks ago


New York, United States BioTalent Full time

Director, Regulatory Affairs, Advertising and Promotion (Ad/Promo) Remote

– United States Seeking a Director of Regulatory Affairs for Advertising and Promotion to lead commercial regulatory strategy and leadership for the US business for a commercialized biopharmaceutical focused on Oncology. This new hire will ensure compliance in US marketing activities by reviewing promotional and non-promotional materials for regulatory adherence and compliance to ensure the Company’s commercial efforts meet regulatory standards while driving business goals and objectives. Seeking a confident leader to advise on promotional regulatory impact for new campaigns and product labeling. You’d be overseeing the regulatory assessment and research on regulatory precedence to evaluate ad/promo issues for various products. Chair the MLR review committee, and serve as FDA (OPDP) liaison,

ensuring timely submissions. The

Director will advise cross-functional teams & stakeholders on commercial

regulatory guidance for corporate communications. You’ll have the opportunity to provide regulatory input to various functional units on promotional labeling for marketed and to-be-marketed drugs and serve as the lead regulatory affairs representative. Qualifications: BS/MS degree in a scientific discipline or equivalent

experience is required (Advanced degree preferred).

9 years in regulatory affairs within biopharmaceutical industry.

5 years of direct experience in regulatory advertising and promotional material review is required.

Direct experience with OPDP as a liaison.

Extensive knowledge of US/EU submissions

Strong working knowledge and experience with FDA regulations

New product launch experience is highly preferred.

Oncology promotion experience is required.

Rare disease promotion experience is a plus.

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