Associate Director Regulatory Affairs
dawar consultingDenver (CO)
Associate Director Regulatory Affairs
Posted yesterday
dawar consultingDenver (CO)
SENIORITY
Manager
About the role
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) \ Company Benefits: \ Medical, Dental, Vision, Paid Sick Leave, 401K \ \ 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. \ \ Review and approve promotional and marketing materials \\ Provide regulatory guidance on advertising and promotional claims \\ Partner with Marketing, Medical, Legal, and Compliance teams \\ Ensure compliance with FDA regulations and healthcare industry guidelines \\\ 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 \\ ~ Excellent communication, stakeholder management, and project leadership skills \\\ Commercial Regulatory Affairs \\ Medical, Legal, Regulatory (MLR) review \\
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