Senior Program Director, Commercial Regulatory Affairs

Senior Program Director (E5A) – Commercial Regulatory Affairs (CORA) San Francisco, CA 94080 (Onsite preferred, remote considered) Full‑Time | Contract | 8‑hour shift | Up to 10% travel Position Summary Commercial Regulatory Affairs (CORA) is responsible for interpreting global health authority requirements and providing regulatory intelligence to support the development, approval, and lifecycle management of pharmaceutical products across all therapeutic areas and phases—from early development through post‑marketing. This role supports U.S. regulatory strategy and execution, ensuring compliance with FDA requirements while enabling innovative, ethical, and effective product communications. Senior Program Directors operate as senior individual contributors responsible for leading complex regulatory initiatives, Program Review Committees (PRCs), and cross‑functional decision‑making activities with limited oversight. Key Responsibilities Lead and chair Program Review Committees (PRCs) for assigned therapeutic or portfolio areas Serve as decision‑maker for regulatory review and approval of advertising and promotional materials Lead complex product launches, combination products, and cross‑functional regulatory initiatives Develop and execute regulatory strategies for marketing, advertising, and FDA communications submissions Represent the organization in FDA interactions, including correspondence and 2253 submissions Interpret FDA regulations, guidance, enforcement trends, and communicate impacts internally Provide regulatory input on promotional concepts and materials Support U.S. labeling strategy and Core Data Sheet (CDS) development Collaborate with commercial, legal, clinical, and regulatory stakeholders Oversee and guide junior regulatory staff and cross‑functional teams Lead process improvement initiatives to enhance regulatory efficiency and compliance Serve as subject‑matter expert on regulatory advertising and promotion matters Qualifications Education Bachelor’s degree required (life sciences, law, business, public policy, or related field) Advanced degree preferred (JD, MBA, MS, PharmD, PhD, or equivalent) Experience 7+ years in regulatory, legal, compliance, policy, or related pharmaceutical industry roles Strong experience in regulatory advertising and promotion preferred 4+ years leading cross‑functional programs or large‑scale initiatives preferred Deep understanding of FDA regulations and healthcare compliance requirements Skills & Competencies Strong regulatory judgment and decision‑making ability Excellent written and verbal communication skills Ability to lead without direct authority and influence senior stakeholders Strong project management and organizational skills Ability to manage complex, cross‑functional regulatory processes Strategic thinking with strong business acumen High ethical standards and compliance mindset Ability to interpret and communicate complex regulatory guidance clearly EEO Statement We are an Equal Opportunity Employer committed to diversity and providing accommodations for individuals with disabilities. #J-18808-Ljbffr Zing Recruiting