Associate Manager, Regulatory Advertising & Promotion
$109,900–$109,900 year
HybridWarren, Michigan, United States or Sleepy Hollow, New York, United States
Job Summary
Manage US regulatory activities for advertising and promotion of marketed products by advising Commercial teams on product message development and reviewing global materials for compliance with FDA and other health authorities. Provide timely regulatory guidance on conference exhibits, disease awareness programs, and speaker activities while maintaining relationships with FDA OPDP reviewers and co-promote partners. Oversee therapeutic areas to ensure promotional submissions meet commercial objectives and corporate integrity, monitor external regulatory changes, and collaborate cross-functionally with Marketing, Medical Affairs, and Legal. Contribute to portfolio-wide standardization of promotional review processes and support labeling development negotiations.
Required Qualifications
- A minimum of 1 to 2 years within regulatory affairs
- preferably within advertising and promotion
- completion of a Post-Doctoral Fellowship Program with related experience focused on Regulatory Affairs, including Advertising and Promotion
- Requires advanced scientific degree (i.e., Masters, PharmD, Ph.D)
- at minimum, a Bachelor's degree (BS) from an accredited college or university in Life Sciences
- Fundamental understanding of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion
- Experience working directly/indirectly with the FDA, specifically OPDP/APLB
- Ability to review promotional materials and interact with FDA OPDP/APLB and help support launch products/campaigns, while maintaining excellent written/verbal communication skill
- Familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations
Desired Qualifications
- Experience with pharmaceutical products is highly preferred
- biologics experience is a plus
- Ability to understand and work with management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.