Director, CMC Regulatory Affairs
New
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
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, covering both drug product and drug substance.
- Extensive command of worldwide CMC regulatory standards and directives for clinical research, trial approvals, and life-cycle management.
- Understanding of US and Ex-US regulations with experience supporting cross-functional teams.
- Demonstrated experience achieving timelines for INDs, IND amendments, NDAs, and meeting packages.
- Ability to assess and manage risks for drug development across regions.
- Excellent verbal and written communication skills.
- Demonstrated cross-functional understanding and technical team support related to CMC aspects of drug development.
- RAC certification is 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 providing drug substance or drug product recommendations for US, EU, and Rest of World (ROW) regulatory requirements.
- Strategize, plan, write, and manage internal/external contributions for region-specific CMC summary submission documents including Module 2, Module 3, and IMPD.
- Deliver high-quality regulatory submissions, strategy, and advice for US, EU, and ROW markets.
- Support the review of investigational product labels, protocols, investigator’s brochures, and other clinical trial materials, and assist with GMP inspections.
- Assess and identify risk mitigation plans based on current and changing US and Ex-US GMP regulations and guidance.
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