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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs and Compliance within the biotech and pharmaceutical industries, with a strong focus on FDA advertising and promotion regulations. Proven ability to lead cross-functional teams and manage promotional review processes effectively.
Highest-signal resume keywords
Regulatory Affairs ExperienceFDA Advertising & Promotion RegulationsPromotional Review Committee LeadershipCross-Functional Team LeadershipStakeholder Management
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory GuidancePromotional Material ReviewCompliance AssuranceForm 2253 SubmissionsAdvertising & Promotion Experience
Soft Skills
Excellent CommunicationProject Leadership
Certifications & Qualifications
Bachelor's DegreeAdvanced Degree Preferred
Industry Keywords
Biotech IndustryPharmaceutical IndustryHealthcare CompliancePromotional Review CommitteeFDA Regulations
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