Job Title: Senior Program Director - Commercial Regulatory Affairs (Advertising & Promotion)

Employment Type: Contract on W2

Workplace Type: Onsite

Duration: 12+ Months (Potential Extension)

Job Description

We are seeking an experienced Senior Program Director - Commercial Regulatory Affairs (Advertising & Promotion) to support one of our leading biotechnology clients. This position will provide strategic regulatory leadership for commercial promotional materials and serve as the regulatory lead across cross-functional review committees.

The ideal candidate will have extensive experience reviewing promotional materials, partnering with Medical, Legal, Marketing, and Compliance teams, and ensuring compliance with FDA promotional regulations.

Key Responsibilities

Lead and chair cross-functional Program Review Committees (PRCs)
Provide regulatory guidance for promotional and advertising materials
Review HCP and patient-facing promotional content
Partner with Medical, Legal, Marketing, Compliance, and Commercial teams
Ensure promotional materials comply with FDA regulations and company policies
Lead regulatory strategy for commercial product launches
Prepare and manage FDA promotional submissions, including Form FDA 2253
Support product labeling and Core Data Sheet activities
Interpret FDA guidance and regulatory changes
Review promotional claims, fair balance, and product messaging
Mentor junior regulatory professionals and support departmental initiatives

Basic Qualifications

Bachelor's degree required
Advanced degree preferred (PharmD, PhD, MS, MBA, JD)
7+ years of Regulatory Affairs, Commercial Regulatory, Advertising & Promotion, Compliance, or Medical/Legal/Regulatory experience within the pharmaceutical or biotechnology industry
Strong FDA promotional compliance knowledge
Experience supporting commercial product launches
Excellent communication and stakeholder management skills

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