DAWAR CONSULTING INC
Senior Program Director (Commercial Regulatory Affairs, Fully Remote)
Be an Early Applicant
Provide strategic regulatory guidance for U.S. commercial pharmaceutical products. Lead Promotional Review Committees, review and approve promotional/marketing materials, advise on advertising claims, support FDA communications and Form 2253 submissions, and partner with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA-compliant communications.
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
Similar Jobs
Big Data • Information Technology • Software • Analytics • Energy
Leads the division’s marketing and sales strategy, overseeing sales teams, advertising sales, customer relationships, market analysis, growth opportunities, pricing, forecasts, and strategic execution. Builds and maintains client accounts, directs internet advertising sales, develops policies and objectives, influences executive leadership, and manages multiple teams through managers and team leaders.
Top Skills:
Generative AiInternet AdvertisingSaaS
Artificial Intelligence • Big Data • Cloud • Information Technology • Software • Big Data Analytics • Automation
Lead strategy, administration, and optimization of AI tools for the SDR organization (Qualified, Gong, Microsoft Co‑Pilot). Identify AI use cases, build implementation roadmaps, define requirements and success metrics, manage pilots and vendors, monitor adoption and impact, maintain governance and documentation, and partner cross-functionally to improve SDR productivity, lead conversion, and pipeline generation.
Top Skills:
6SenseAi ToolsChatbotsConversational Marketing PlatformsGongGong Agent StudioLeandataMarketoMicrosoft Co-PilotQualifiedSales Engagement PlatformsSalesforce
Big Data • Information Technology • Software • Analytics • Energy
Processes high-volume purchase order and non-purchase order invoices, verifies coding and approvals, resolves discrepancies, reconciles vendor statements, and maintains accurate vendor records. Handles vendor correspondence, documentation, payment processing, discounts, and compliance checks, including vendor addresses and Federal ID numbers. Supports county payments, month-end close activities, reporting, and efficient accounts payable operations while maintaining confidential records.
Top Skills:
Accounting Software SystemsMS Office
What you need to know about the San Francisco Tech Scene
San Francisco and the surrounding Bay Area attracts more startup funding than any other region in the world. Home to Stanford University and UC Berkeley, leading VC firms and several of the world’s most valuable companies, the Bay Area is the place to go for anyone looking to make it big in the tech industry. That said, San Francisco has a lot to offer beyond technology thanks to a thriving art and music scene, excellent food and a short drive to several of the country’s most beautiful recreational areas.
Key Facts About San Francisco Tech
- Number of Tech Workers: 365,500; 13.9% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Google, Apple, Salesforce, Meta
- Key Industries: Artificial intelligence, cloud computing, fintech, consumer technology, software
- Funding Landscape: $50.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Sequoia Capital, Andreessen Horowitz, Bessemer Venture Partners, Greylock Partners, Khosla Ventures, Kleiner Perkins
- Research Centers and Universities: Stanford University; University of California, Berkeley; University of San Francisco; Santa Clara University; Ames Research Center; Center for AI Safety; California Institute for Regenerative Medicine
