Senior Program Director, Commercial Regulatory Affairs

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...

Ready to Apply?

Submit your application today and join our talented team at System One.

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