Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling
New
J
JobgetherBiopharmaceutical
Remote position within the United States, West Coast working hours are preferred.Full-TimeDirector
SalaryAnnual base salary: $180,000–$205,000 USD. Annual bonus: Eligible for an annual performance bonus. Equity compensation: Eligible for equity awards and participation in the company's stock plan.
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Job Details
- Experience
- At least 8 years of biopharmaceutical regulatory affairs experience, including a minimum of 6 years in advertising and promotion or equivalent regulatory work.
- Required Skills
- Project Management
Requirements
- Hold a bachelor's or master's degree with relevant professional experience.
- Have at least 8 years of biopharmaceutical regulatory affairs experience, including a minimum of 6 years in advertising and promotion or equivalent regulatory work.
- Bring expert knowledge of FDA promotional regulations, product labeling requirements, MLR review processes, promotional submissions, and OPDP interactions.
- Demonstrate experience supporting product launches and lifecycle management.
- Understand promotional and non-promotional communications, claims substantiation, fair balance, and alignment with approved product labeling.
- Have experience developing and maintaining core and local product labeling, coordinating global implementation, and supporting health authority negotiations.
- Be familiar with Veeva PromoMats or comparable promotional review and content management systems.
- Bring leadership, scientific judgment, and project management skills to influence cross-functional stakeholders and navigate complex regulatory decisions.
- Assess regulatory risk and interpret complex requirements while supporting business objectives and patient safety.
- An advanced life sciences or medical degree, such as an MD, PhD, or PharmD, is preferred.
- Be willing to travel approximately 20%.
Responsibilities
- Lead promotional and medical review committees, providing risk-based guidance on product claims, supporting evidence, fair balance, and multichannel communications.
- Advise on advertising, promotional, and educational materials across print, digital, social media, speaker programs, and formulary communications.
- Lead engagements with FDA's Office of Prescription Drug Promotion and, where applicable, the Advertising and Promotional Labeling Branch.
- Direct the development and maintenance of core, U.S., and patient labeling, coordinating cross-functional alignment and global implementation.
- Develop and execute global implementation plans for labeling updates based on new safety and efficacy data.
- Establish and improve review workflows, standard operating procedures, systems, and training.
- Monitor regulatory guidance, enforcement trends, and the competitive landscape, and advise senior leadership on risks and mitigation.
- Partner with Commercial, Medical Affairs, Legal, Compliance, and global regulatory stakeholders on product communications and labeling.
- Oversee vendors, budgets, and resources supporting regulatory activities.
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