Senior Director, Regulatory Advertising & Promotion (Oncology)

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

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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