Associate Director, Global Regulatory Advertising and Promotion

Ensure compliance with regulatory requirements for promotional and non-promotional materials across various communication channels. Serve as a key liaison between Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic regulatory guidance on advertising and promotional activities.

Responsibilities

• Review and approve promotional materials, corporate communications, and disease awareness campaigns to ensure compliance with FDA and other applicable regulatory requirements.
• Guide promotional strategy as the Regulatory Ad Promo representative during early stages of product development.
• Maintain up-to-date knowledge of regulatory requirements, enforcement trends, and industry best practices.
• Lead discussions for assigned products during the Promotional Material Review Team (PMRT) and Medical Review Committee (MRC), working closely with Marketing, Medical, Legal, and Compliance teams to develop impactful material that aligns with regulatory expectations.
• Support interactions with the FDA’s Advertising and Promotional Labeling Branch (APLB) and other regulatory authorities as needed.
• Prepare regulatory submissions for promotional materials, including 2253 filings and advisory comments requests.
• Address regulatory queries from health authorities regarding promotional and advertising content.
• Develop and deliver training programs on promotional regulations for internal stakeholders.
• Help refine internal SOPs, best practices, and review processes for advertising and promotion compliance.
• Monitor and analyze enforcement actions and industry trends to proactively mitigate regulatory risks.

Requirements

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline). Advanced degree (PharmD, JD, or Master’s in Regulatory Affairs) preferred.
• Minimum 5 years of experience in Regulatory Affairs, with at least 2 years focused on advertising and promotion in the pharmaceutical, biotech, or medical device industry.
• Strong knowledge of applicable regulations and enforcement trends.
• Prior experience working with cross-functional review committees in a regulated environment.
• Global regulatory knowledge (EMA, Health Canada, UK, etc.) is a plus.

Skills

• Deep understanding of US and global regulatory frameworks for advertising and promotion.
• Excellent ability to interpret and apply regulatory guidelines and requirements in a business-focused, solutions-oriented manner.
• Strong written and verbal communication skills, with experience in preparing regulatory documentation.
• Ability to work cross-functionally and manage multiple projects in a fast-paced environment.
• Strong attention to detail and problem-solving skills.
• Familiarity with digital and social media promotional compliance is a plus.
• Experience in infectious diseases, oncology, rare diseases, and/or vaccines is a plus.

Pay

The potential base pay range for this role, when annualized, is $103,600.00 - $288,600.00. The actual base pay offered may vary based on job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.