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Full-Time

Senior Director

Commercial Regulatory Affairs

Confirmed live in the last 24 hours

Revolution Medicines

Revolution Medicines

201-500 employees

Specializes in precision oncology therapies

Biotechnology

Compensation Overview

$235k - $281kAnnually

+ Equity Awards

Expert

San Carlos, CA, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
Requirements
  • Bachelor’s degree in science or equivalent experience.
  • 13+ years’ experience in promotional regulatory affairs (drugs).
  • Strong knowledge of FDA promotional regulations, guidance, best practices, and their evolution.
  • Strong, current understanding of “scientific exchange” and pre-approval discussions.
  • Confident in interactions with commercial and medical affairs leaders.
  • Collaborative and solution-oriented mindset and approach.
  • Strong verbal and written communication and influencing skills.
  • Exemplary compliance ethics and high concern for standards.
  • Strong strategic and analytical thinking and decision-making skills.
Responsibilities
  • Establish the commercial regulatory function at Revolution Medicines.
  • Lead and participate on cross-functional teams to assess and mitigate regulatory and compliance risks related to commercialization of drug products.
  • Collaborate on or lead new processes and review systems to support commercialization (e.g., Standard Operating Procedures, Veeva PromoMats, Veeva MedComms).
  • Collaborate with relevant commercial and medical stakeholders to ensure business objectives are achieved in a compliant manner.
  • Train the company at all levels on regulatory expectations and requirements at different phases of the product lifecycle, including pre-approval discussions.
  • Serve as an assigned contact and maintain a positive relationship with the US FDA Office of Prescription Drug Promotion (OPDP).
  • Provide promotional regulatory strategy and prepare submission of materials at the time of dissemination (Form FDA 2253) or for advisory comment requests.
  • Ensure the company is launch-ready and regulatory is appropriately resourced to ensure success.

### Welcome to Revolution Medicines, crafting the future of oncology with precision. Our focus is on advancing RAS(ON) inhibitors and RAS Companion inhibitors, marked by the remarkable journey of our lead product, RMC-4630, through its clinical phases. Supported by a team of passionate oncology experts, we are steadfast in our mission to develop treatments that precisely target oncogenic mutations, promising a brighter, healthier tomorrow for patients everywhere. ###

Company Stage

IPO

Total Funding

$1.3B

Headquarters

Redwood City, California

Founded

2014

Growth & Insights
Headcount

6 month growth

14%

1 year growth

42%

2 year growth

92%