​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.