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Senior Program Director (Commercial Regulatory Affairs, Fully Remote)

DAWAR CONSULTING INC

Role overview

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
  • 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

Key facts

Hard skills

FDA Regulations Promotional Campaigns Medical Law Project Management Product Launch Readiness

Other skills

  • Communication

About the company

DAWAR CONSULTING INC logo

DAWAR CONSULTING INC

Business Consulting & Services

DAWAR CONSULTING, a trusted name in IT Professional Services and Staff Augmentation, delivers innovative Workforce solutions to support our clients business needs and growth strategy.Our Professional Services practice includes – Pre & Post Implementation of Workday (HCM & Financial platform) and ServiceNow (ITSM, Digital Transformation, and Helpdesk). We are committed to deploying industry standard tools and services from evaluation, design, implementation, testing, integration, and post go-live support. Our Staffing Services practice includes - Nearshore, Offshore and On-Demand Talent Management; Contingent Staffing, Permanent Hire and Managed Services SOW's for both domestic and international clients.

Company details

Company typeSME
IndustryBusiness Consulting & Services
Company size51 - 200

Links

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Job description

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

If interested, please share your updated resume at hr@dawarconsulting.com/lakshmi@dawarconsulting.com

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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