Director, CMC Regulatory Affairs
New
R
RecursionBiotech Pharmaceutical
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
- 8+ years’ experience in CMC regulatory
Requirements
- Deep technical knowledge of small molecule drug development.
- BA/BS, MS or PhD in a relevant technical discipline.
- 8+ years of experience in CMC regulatory (both drug product and drug substance).
- Extensive command of worldwide CMC regulatory standards and directives for facilitating clinical research.
- Understanding of US and Ex-US regulations and ability to provide strategic advice.
- Demonstrated track record of authoring and producing high-quality INDs, IND amendments, NDAs, and meeting packages.
- Demonstration of cross-functional understanding and technical team support related to CMC aspects of drug development.
- Experience managing multiple projects and priorities.
- Excellent verbal and written communication skills.
- RAC certification preferred.
Responsibilities
- Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 clinical trials and marketing applications.
- Influence regulatory strategy by attending team meetings and providing drug substance or drug product recommendations.
- Strategize, plan, write, and manage internal and external contributors for CMC summary submission documents (Module 2, Module 3, IMPD, etc.).
- Deliver high-quality US, EU, and ROW regulatory submissions, strategy, and advice.
- Support the review of investigational product labels, protocols, investigator’s brochures, and other clinical trial materials, including GMP inspections.
- Assess and identify risk mitigation plans based on current and changing US and Ex-US GMP regulations.
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