Hamlyn Williams
Senior Director, Regulatory Advertising & Promotion (Oncology) Job at Hamlyn Wil
Hamlyn Williams, Trenton, NJ, US, 08628
Senior Director, Regulatory Advertising & Promotion (Oncology) Senior Director, Regulatory Advertising & Promotion (Oncology) 1 day ago Be among the first 25 applicants
This range is provided by Hamlyn Williams. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $280,000.00/yr - $300,000.00/yr
Direct message the job poster from Hamlyn Williams
Hamlyn Williams is partnered with a global pharmaceutical organization looking to hire a Head of Regulatory Ad/Promo at Senior Director-level. This is ideally based one-day-per-week in New Jersey but this organization will also consider East Coast based candidates.
Role: Senior Director, Regulatory Advertising & Promotion
Type: Full-Time
Overview: Hamlyn Williams is seeking an experienced regulatory leader to oversee all compliance aspects of advertising and promotional materials for pharmaceutical and biopharmaceutical products for this organization, with a strong focus on their Oncology product line. This pivotal role ensures strategic alignment between promotional efforts and regulatory requirements, while supporting commercial and medical objectives through rigorous oversight and trusted cross-functional leadership.
Key Responsibilities
Strategic Oversight:
Design and execute regulatory strategies for promotional content, ensuring consistency with FDA/OPDP requirements and internal policies.
Navigate the interplay between labeling changes and promotional messaging, ensuring alignment with commercial goals.
Cross-Functional Collaboration:
Act as the central regulatory advisor for Marketing, Medical Affairs, Legal, and other stakeholders.
Chair or participate actively in promotional material review processes, ensuring materials are accurate, balanced, and compliant.
Regulatory Engagement:
Serve as the main liaison with the FDA’s Office of Prescription Drug Promotion (OPDP), managing submissions (e.g., Form 2253) and advising on feedback.
Maintain awareness of regulatory trends, guidance updates, and enforcement patterns, translating these insights into actionable advice.
Lead and mentor a team of regulatory professionals, fostering a culture of continuous improvement, collaboration, and regulatory excellence.
Identify and mitigate promotional compliance risks proactively.
Develop and deliver targeted training for internal teams to enhance regulatory awareness and minimize potential compliance gaps.
Qualifications:
Advanced degree (e.g., PharmD, PhD, MS or JD) in a relevant scientific or regulatory discipline preferred.
Oncology focus is essential.
Minimum of 8-10 years in regulatory affairs, with a strong focus on advertising and promotion.
Direct experience with US FDA promotional review processes, including advisory submissions and enforcement letters.
Demonstrated ability to interpret and navigate complex regulatory landscapes and industry guidance.
Strong leadership, analytical, and communication skills; adept at influencing cross-functional stakeholders and driving consensus.
Seniority level Seniority level Director
Employment type Employment type Full-time
Job function Job function Science and Quality Assurance
Industries Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Hamlyn Williams by 2x
Inferred from the description for this job Medical insurance
Vision insurance
401(k)
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