Senior Program Director (Commercial Regulatory Affairs, Fully Remote)

Dawar Consulting, Inc.; United States; Remote; USD 165.000 - 175.000; Vollzeit

Zusammenfassung

Dawar Consulting, Inc. is seeking a Senior Program Director, Commercial Regulatory Affairs to lead regulatory strategy for U.S. commercial products from a fully remote position in the United States. The role emphasizes PRC leadership, review of promotional materials, and FDA-compliant communications.

The candidate will partner with Marketing, Medical, Legal, and Compliance to ensure FDA regulations are met and to support Form 2253 submissions in a fast-paced biotech environment.

Qualifikationen

• Bachelor's degree required; advanced degree preferred (PharmD, PhD, JD, MBA, MS).
• 7+ years in Regulatory Affairs, Commercial Regulatory, Compliance, or Advertising & Promotion in biotech/pharma.
• Strong knowledge of FDA advertising & promotion regulations, PRC processes, and healthcare compliance.
• Experience leading cross-functional teams and Promotional Review Committees (PRCs).
• Excellent communication, stakeholder management, and project leadership.

Aufgaben

• 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.

Kenntnisse

Regulatory affairs

Cross-functional leadership

Communication

Project leadership

Stakeholder management

PRC leadership

Ausbildung

Bachelor's degree

Advanced degree (PharmD, PhD, JD, MBA, MS)

Jobbeschreibung

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) Pay Rate: $120-$127/hr on W2 Company Benefits: Medical, Dental, Vision, Paid Sick Leave, 401K

Job Summary 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.

Key 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

Qualifications

• 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

Preferred Skills

• Commercial Regulatory Affairs
• Advertising & Promotion (Ad/Promo)
• Promotional Review Committee (PRC)
• FDA Form 2253
• Medical, Legal, Regulatory (MLR) review
• Product launch support