Senior Program Director (Commercial Regulatory Affairs, Fully Remote)

dawarconsulting; South San Francisco (CA); Remote; USD 165,000 - 175,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Paid Sick Leave

401K

Job summary

dawarconsulting is seeking a Senior Program Director of Commercial Regulatory Affairs to lead PRC meetings, review promotional materials, and provide FDA compliance guidance. You will collaborate with Marketing, Medical, Legal, and Compliance teams to ensure accurate regulatory submissions and robust promotional review processes.

The role supports FDA communications, Form 2253 submissions, and strict adherence to healthcare advertising rules, in a fully remote, long-term contract with

Qualifications

• Bachelor's degree required; advanced degree preferred in biotech/pharma or related field.
• 7+ years of Regulatory Affairs, Commercial Regulatory, Compliance, or Advertising & Promotion experience in biotech/pharmaceuticals.
• Strong knowledge of FDA advertising & promotion regulations and PRC processes.
• 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.]
• CoT_job_summary_short':'COMPANY NAME: dawarconsulting\nKEY POINTS: Regulatory affairs lead, PRC leadership, FDA promo expertise','job_summary_short':'<p>dawarconsulting seeks a Senior Program Director for Commercial Regulatory Affairs. The role manages PRCs, reviews promotional materials, and guides advertising compliance while coordinating with Marketing, Medical, Legal, and Compliance teams.</p><p>You'll support FDA communications, Form 2253 submissions, and ensure adherence to FDA rules and healthcare guidelines in a fully remote, long-term contract setting.</p>'
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Skills

Regulatory affairs

Cross-functional leadership

Communication

Stakeholder management

Project leadership

Education

Bachelor's degree

Advanced degree preferred

Job description

"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

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