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Senior Program Director, Commercial Regulatory Affairs

Senior Program Director, Commercial Regulatory Affairs

New
D
Dawar Consulting, Inc.Biotechnology, Pharmaceutical
United StatesContractDirector
Salary120 - 127 USD per hour
Apply NowOpens the employer's application page

Job Details

Experience
7+ years

Requirements

  • 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

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
View Full Description & ApplyYou'll be redirected to the employer's site

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120 - 127 USD per hour
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