Senior Program Director, Commercial Regulatory Affairs

Job Description

Job Description

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

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Zing Recruiting, a leader in the staffing industry for the past 33 years, continues our vision of ‘linking’ communities through employment. Zing Recruiting’s dedication to the safety, health & well-being of our associates, clients and communities remains our #1 priority. Zing Recruiting is proud to be an EEOE, M/F/D/V, and we are committed to diversity both in practice and spirit at all levels of the organization and encourage individuals with disabilities to apply. We are dedicated to providing accommodations for those in need.
Company Description

Zing Recruiting is dedicated to delivering candidates and client’s alike a great experience for each unique position. We specialize in finding dedicated professionals with the education, talent, and fresh perspectives – professionals at the top of their game. Professionals who have what it takes to be competitive and innovative in today’s market. We work to match candidates needs and requirements to our clients’ requirements and expectations. We work to find the right “fit” for both candidate and client.

Company Description

Zing Recruiting is dedicated to delivering candidates and client’s alike a great experience for each unique position. We specialize in finding dedicated professionals with the education, talent, and fresh perspectives – professionals at the top of their game. Professionals who have what it takes to be competitive and innovative in today’s market. We work to match candidates needs and requirements to our clients’ requirements and expectations. We work to find the right “fit” for both candidate and client.