Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling

Accountabilities

• Lead promotional and medical review: Serve as the regulatory lead for promotional and medical review committees, providing practical, risk-based guidance on product claims, supporting evidence, fair balance, and multichannel communications.

• Guide promotional strategy: Provide proactive regulatory advice on advertising, promotional, and educational materials across print, digital, social media, speaker programs, and formulary communications, ensuring consistency with the U.S. Prescribing Information (USPI) and applicable regulations.

• Manage health authority interactions: Lead engagements with the U.S. Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) and, where applicable, the Advertising and Promotional Labeling Branch (APLB), including advisory comment requests and responses to enforcement correspondence.

• Drive labeling strategy: Direct the development and maintenance of core, U.S., and patient labeling, coordinating cross-functional alignment, global implementation, and health authority negotiations.

• Support global regulatory alignment: Collaborate with Global Regulatory Leads on labeling negotiations and ensure approved labeling appropriately supports commercialization objectives while meeting regulatory requirements.

• Oversee labeling implementation: Develop and execute global implementation plans that incorporate new safety and efficacy data, supporting timely distribution and compliant use of updated labeling across markets.

• Improve regulatory processes: Establish and enhance review workflows, standard operating procedures (SOPs), systems, and training to strengthen compliance, consistency, and operational effectiveness.

• Monitor regulatory developments: Track changes in regulatory guidance, enforcement trends, and the competitive landscape; advise senior leadership on emerging risks and appropriate mitigation strategies.

• Partner across functions: Work closely with Commercial, Medical Affairs, Legal, and Compliance to enable effective product communications that align with approved labeling and applicable U.S. and international requirements.

• Manage resources and external partners: Oversee vendors, budgets, and resources to support efficient delivery of regulatory activities.

• Travel as needed: Travel approximately 20% to support business priorities and cross-functional collaboration.

Requirements

• Bachelor's or master's degree with relevant professional experience; an advanced life sciences or medical degree, such as an MD, PhD, or PharmD, is preferred.

• At least 8 years of biopharmaceutical regulatory affairs experience, including a minimum of 6 years in advertising and promotion or equivalent regulatory work.

• Expert knowledge of FDA promotional regulations, product labeling requirements, medical-legal-regulatory (MLR) review processes, promotional submissions, and OPDP interactions.

• Demonstrated experience supporting product launches and lifecycle management, ideally within a growth-stage biotechnology company.

• Strong understanding of promotional and non-promotional communications, claims substantiation, fair balance, and alignment with approved product labeling.

• Experience developing and maintaining core and local product labeling, coordinating global implementation, and supporting health authority negotiations.

• Familiarity with Veeva PromoMats or comparable promotional review and content management systems.

• Strong leadership, scientific judgment, and project management skills, with the ability to influence cross-functional stakeholders and navigate complex regulatory decisions.

• Excellent written and verbal communication skills, including the ability to explain regulatory considerations clearly and provide practical guidance to senior stakeholders.

• A collaborative, solutions-oriented approach and a track record of delivering creative, balanced, and realistic recommendations to Commercial and Medical Affairs teams.

• Ability to assess regulatory risk, interpret complex requirements, and support business objectives without compromising compliance or patient safety.

• Ability to work remotely and collaborate across teams; West Coast working hours are preferred.

• Willingness to travel approximately 20%.

Benefits

• Annual 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.

• Work arrangement: Remote position within the United States, with West Coast hours preferred.

• Employment type: Full-time.

• Compensation flexibility: Final salary may vary based on experience, education, geographic location, internal equity, and market data.

• Additional benefits: A benefits package is offered; specific details regarding healthcare coverage, paid time off, retirement plans, and other perks are not provided in the job description and should be confirmed during the hiring process.

• Professional impact: Opportunity to influence regulatory strategy, product communications, and labeling across the product lifecycle in a specialized biopharmaceutical environment.