The Associate Director, Advertising, Promotion and Labeling will execute regulatory oversight for advertising, promotion, medical communications, and product labeling from pre-launch planning through lifecycle management. This is a critical role responsible for developing and executing regulatory strategy for all product communications and core labeling. This role will ensure that commercial and non-promotional materials, as well as core and local product labeling, are compliant with US FDA, EMA, and other relevant global regulations. The role requires expert-level interpretation of complex regulatory requirements and a proven ability to influence cross-functional teams to achieve both compliance and business goals.
Title: Associate Director, Advertising, Promotion and Labeling
Location: Remote (West Coast hours preferred)
Reports to: SVP, Chief Regulatory Officer
Responsibilities
Serve as regulatory lead for promotional and medical review committees, providing practical, risk-based guidance on claims, supporting evidence, fair balance, and multichannel communications.
Provide strategic, proactive regulatory guidance on the development of all promotional, advertising, and educational materials across all channels (print, digital, social media, speaker programs, formulary communications) to ensure fair balance and consistency with the US Prescribing Information (USPI).
Lead interactions with the US FDA Office of Prescription Drug Promotion (OPDP) and, where applicable, the Advertising and Promotional Labeling Branch (APLB), including pre-submission requests for advisory comments and managing responses to enforcement letters.
Direct development and maintenance of core, U.S., and patient labeling; lead cross-functional labeling alignment, global implementation, and support health authority negotiations.
Establish and improve review processes, SOPs, systems, and training; monitor regulatory guidance and enforcement trends to mitigate risk.
Partner with Commercial, Medical Affairs, Legal, and Compliance to enable effective communications consistent with approved labeling and applicable U.S. and global requirements.
Requirements
Expertise in FDA promotional regulations, labeling, MLR review, promotional submissions, and OPDP interactions.
Strong leadership, scientific judgment, communication, and project management skills, with a collaborative, solutions-oriented approach.
180000 - 205000 USD a year
The national salary range for this position is $180,000. to $205,000. USD annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on factors including experience, education, geographic location, internal equity, and market data. This position is also eligible for annual bonus, equity, benefits, and participation in the Company’s stock plan.
