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Senior Program Director, Commercial Regulatory Affairs
DAWAR CONSULTING INCSenior Program Director providing regulatory guidance for U.S. commercial pharmaceutical products at a leading biotech firm.
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Medical
- Dental
- Vision
- Paid Sick Leave
- 401K
ATS Keywords
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Hard Skills & Tools
Regulatory GuidancePromotional Material ReviewCompliance AssuranceForm 2253 SubmissionsAdvertising & Promotion Experience
Soft Skills
Excellent CommunicationProject Leadership
Certifications
Bachelor's DegreeAdvanced Degree Preferred