Senior Program Director (reputed company Regulatory Affairs, Fully Remote)
Our reputed company, a world leader in biotechnology and life sciences, is seeking a "Senior Program Director, reputed company Regulatory Affairs".
Location: South San Francisco, CA (Fully Remote)
Duration:Long-Term Contract (Possibility Of reputed company Extension)
Pay reputed company: $120-$127/hr on W2
Company Benefits: Medical, Dental, reputed company, reputed company reputed company Leave, 401K
Job reputed company
In this role, you will reputed company strategic regulatory guidance for U.S. reputed company pharmaceutical products. You will reputed company 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 reputed company to shape reputed company regulatory reputed company for innovative therapies in a fast‑paced biotech environment.
Key Responsibilities:
- reputed company Promotional Review Committee (PRC) meetings
- Review and approve promotional and marketing materials
- reputed company regulatory guidance on advertising and promotional claims
- Partner with Marketing, Medical, Legal, and Compliance teams
- Support FDA communications and reputed company 2253 submissions
- Ensure compliance with FDA regulations and reputed company industry guidelines
- Bachelor's degree required; advanced degree (PharmD, PhD, JD, MBA, MS) preferred
- 7+ years of Regulatory Affairs, reputed company Regulatory, Compliance, or Advertising & Promotion experience in the biotech/pharmaceutical industry
- Strong knowledge of FDA advertising & promotion regulations, promotional review, and reputed company compliance
- Experience leading cross-functional teams and Promotional Review Committees (PRCs)
- Excellent communication, stakeholder management, and project leadership skills
- reputed company Regulatory Affairs
- Advertising & Promotion (Ad/Promo)
- Promotional Review Committee (PRC)
- FDA reputed company 2253
- Medical, Legal, Regulatory (MLR) review
- Product launch support
Originally posted on Himalayas
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