Remote Senior Regulatory Programs Lead - Commercial Pharma

Dawar Consulting, Inc.; United States; Remote; USD 165,000 - 175,000; Full time

Job summary

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.

Qualifications

• 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.

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.

Skills

Regulatory affairs

Cross-functional leadership

Communication

Project leadership

Stakeholder management

PRC leadership

Education

Bachelor's degree

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

Job description

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.