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Senior Program Director, Commercial Regulatory Affairs

System One • South San Francisco, CA • 3h ago

Job Title: Senior Program Director, Commercial Regulatory Affairs

Location: South San Francisco CA

Type: Contract

Compensation: $120.00 - $122.40

Work Model: Remote

Hours: 40.0

Responsibilities

Lead Program Review Committees (PRCs) independently, managing complex product launches and cross-functional activities.

Act as the primary decision-maker for PRCs within your designated therapeutic or business area.

Develop and implement regulatory strategies, including preparing and submitting applications to health authorities.

Communicate effectively with the FDA and other regulatory bodies, sign-off on submissions, and address comments or requests.

Support development of cross-functional regulatory strategies, providing insights and recommendations.

Represent the company in official FDA communications and ensure compliance with evolving regulations.

Guide and mentor junior team members, fostering a collaborative and compliant work environment.

Participate in ad hoc projects and cross-functional teams to advance regulatory and organizational goals.

Requirements

Bachelor's Degree in life sciences, law, public policy, marketing, business, education, or related discipline. Graduate-level Degree (JD, MBA, MS, PharmD, PhD) preferred.

7+ years of experience in regulatory, legal, compliance, or related disciplines within the bio/pharma industry.

Regulatory advertising and promotion experience strongly preferred.

4+ years of experience leading large-scale, cross-functional project teams or strategic initiatives.

In-depth knowledge of the bio/pharma industry, including compliance, legal, clinical, regulatory, and marketing aspects.

Strong influencing, negotiation, and communication skills, capable of guiding stakeholders at all levels.

Excellent project management skills with the ability to prioritize and coordinate multiple initiatives.

Ability to manage change effectively and foster innovation across teams.

Willingness to travel approximately 10% of the time.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

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