What are the responsibilities and job description for the Senior Program Director, Commercial Regulatory Affairs position at Pharmaceutical Company?
Job Title: Senior Program Director - Commercial Regulatory Affairs (Advertising & Promotion)
Employment Type: Contract on W2
Workplace Type: Onsite
Location: South San Francisco, CA
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
Required Skills
- Commercial Regulatory Affairs
- Advertising & Promotion (Ad/Promo)
- Medical Legal Regulatory (MLR)
- Program Review Committee (PRC)
- FDA Promotional Regulations
- OPDP
- FDA Form 2253
- Promotional Review
- Promotional Labeling
- Medical Claims Review
- Fair Balance
- ISI
- Product Labeling
- Regulatory Strategy
- Cross-functional Leadership
Preferred Skills
- Veeva Vault PromoMats
- Promotional Compliance
- Healthcare Compliance
- Product Launch Experience
- Oncology or Specialty Pharma Experience
- FDA Communications
- Medical Affairs Collaboration