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The Role
Provide strategic regulatory guidance for U.S. commercial pharmaceutical products. Lead Promotional Review Committees, review and approve promotional/marketing materials, advise on advertising claims, support FDA communications and Form 2253 submissions, and partner with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA-compliant communications.
Summary Generated by Built In
Our client, a world leader in biotechnology and life sciences, is seeking a "Senior Program Director, Commercial Regulatory Affairs".
Location: South San Francisco, CA (Fully Remote)
Duration: Long-Term Contract (Possibility Of Further Extension)
Pay Rate: $120-$127/hr on W2
Company Benefits: Medical, Dental, Vision, Paid Sick Leave, 401K
Job Summary
In this role, you will provide strategic regulatory guidance for U.S. commercial pharmaceutical products. You will lead Promotional Review Committees (PRCs), review and approve advertising and promotional materials, and partner closely with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA‑compliant communications. This position offers the opportunity to shape commercial regulatory strategy for innovative therapies in a fast‑paced biotech environment.
Key Responsibilities:
- Lead Promotional Review Committee (PRC) meetings
- Review and approve promotional and marketing materials
- Provide regulatory guidance on advertising and promotional claims
- Partner with Marketing, Medical, Legal, and Compliance teams
- Support FDA communications and Form 2253 submissions
- Ensure compliance with FDA regulations and healthcare industry guidelines
Qualifications:
- Bachelor's degree required; advanced degree (PharmD, PhD, JD, MBA, MS) preferred
- 7+ years of Regulatory Affairs, Commercial Regulatory, Compliance, or Advertising & Promotion experience in the biotech/pharmaceutical industry
- Strong knowledge of FDA advertising & promotion regulations, promotional review, and healthcare compliance
- Experience leading cross-functional teams and Promotional Review Committees (PRCs)
- Excellent communication, stakeholder management, and project leadership skills
Preferred Skills:
- Commercial Regulatory Affairs
- Advertising & Promotion (Ad/Promo)
- Promotional Review Committee (PRC)
- FDA Form 2253
- Medical, Legal, Regulatory (MLR) review
- Product launch support
Skills Required
- Bachelor's degree
- Advanced degree (PharmD, PhD, JD, MBA, MS)
- 7+ years Regulatory Affairs, Commercial Regulatory, Compliance, or Advertising & Promotion experience in biotech/pharmaceutical industry
- Strong knowledge of FDA advertising & promotion regulations, promotional review, and healthcare compliance
- Experience leading cross-functional teams and Promotional Review Committees (PRCs)
- Experience supporting FDA communications and submitting FDA Form 2253
- Excellent communication, stakeholder management, and project leadership skills
- Commercial Regulatory Affairs experience
- Advertising & Promotion (Ad/Promo) expertise
- Experience with MLR (Medical, Legal, Regulatory) review
- Product launch support experience
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The Company
What We Do
Dawar Consulting Inc. is a professional services and staff augmentation firm specializing in IT consulting, workforce solutions, and HCM/HRIS services. They provide technology and business consulting, project delivery, and IT support to help clients achieve their strategic goals. With expertise across IT, Engineering, and Finance, they deliver best-in-class workforce solutions and innovative strategies to drive operational efficiency and business success.
