Director, Regulatory Affairs
New
R
RecursionBiotechnology, Pharmaceuticals
This role is remote-friendly, with most work conducted from home.Full-TimeDirector
SalaryNew York City, Boston, & San Francisco Bay Area(s): $228,250–$280,720; Salt Lake City & all other U.S. locations: $207,500–$255,200
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Job Details
- Experience
- A minimum of 10 years in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs.
Requirements
- Minimum 10 years of experience in the pharmaceutical industry.
- Minimum 8 years of experience in Global Regulatory Affairs.
- Demonstrated experience with major Health Authorities including US FDA, Health Canada, UK MHRA, and EMA.
- Minimum 8 years of experience with regulatory submissions (IND, NDA, NDS, MAA, PIP/PSP, ODD, BTD).
- Expertise in regulatory strategy development and operational implementation.
- Strong organizational awareness with experience working cross-functionally on global teams.
- Excellent interpersonal, communication, negotiation, and problem-solving skills.
- Ability to manage complex issues and coordinate multiple projects simultaneously.
Responsibilities
- Support global regulatory strategy and manage day-to-day regulatory activities for products through all stages of development.
- Identify and manage regulatory risks, providing guidance to cross-functional leads and clinical study teams.
- Lead or serve as primary point of contact for interactions with major Health Authorities (FDA, EMA, MHRA, Health Canada).
- Oversee the preparation, review, and quality control of critical regulatory documentation and submissions.
- Collaborate with internal functions including Clinical, Commercial, and Medical Affairs to support global drug development goals.
- Interpret regulatory guidelines and develop communication plans to assess impact on programs.
- Monitor global regulatory intelligence to maintain compliance and shape internal strategy.
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