The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non‑promotional materials across various communication channels. This role will serve as a key liaison between Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic regulatory guidance on advertising and promotional activities. The ideal candidate will have expertise in FDA regulations, OPDP (Office of Prescription Drug Promotion)/Advertising and Promotional Labeling Branch (APLB) guidance, and industry best practices.
Regulatory Compliance & Review
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.
Cross‑Functional Collaboration
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.
Health Authority Interactions
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.
Training & Process Improvement
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.
Education
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.
Qualifications & Experience
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.
Experience
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.
Preferred Qualifications
Familiarity with digital and social media promotional compliance.
Experience in infectious diseases, oncology, rare diseases, and/or vaccines is a plus.
Compensation & Benefits
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 a number of factors including job‑related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part‑time). Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered in addition to a range of health, welfare, and/or other benefits.
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
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Associate Director, Global Regulatory Advertising and Promotion
IQVIA · Multiple locations ·
- Pay:
- $103,600-$288,600/yr
- Job type:
- Full Time