Director, Promotional Regulatory Affairs

Director, Promotional Regulatory Affairs

Delaware - United States

The Director, Promotional Regulatory Affairs will be responsible for overseeing the regulatory assessment and research on regulatory precedence, in order to evaluate advertising/promotional regulatory issues for various products. There's a new product launch and this new hire will be expected to lead, develop, and review regulatory strategies for all promotional materials for marketed and pipeline products. 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.

• Point of contact with the FDA Office of Prescription Drug Promotion (OPDP)
• Leading the planning, execution, and assessment of product life cycle management activities and strategies
• Lead the promotional material review committee (PMRC) process for assigned products and create all materials to meet FDA regulations and company objectives.
• Ability to work cross-functionally and collaboratively with compliance, medical, legal, and commercial entities and applies expertise and influence to ensure the development of promotional programs are all in compliance with regulations and company goals.
• Provide guidance and expertise on new marketing concepts and promotional strategies for assigned products.
• Lead and prep submission of INDs/CTAs/MAAs/NDAs/BLAs
• Ensure all promotional content, quality, precision as well as format of submissions comply with internal procedures and FDA guidances.
• Leading and liaising Health Authorities' interactions

Qualifications:

• BS/MS degree in a scientific discipline or equivalent experience is required (Advanced degree preferred), with at least 5 years of pharmaceutical industry experience, including 5 years of direct experience in 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.

If you meet the above qualifications & interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com.