Manager/Senior Manager, Regulatory CMC
$115,000–$145,000 year
On-site · New York City, New York, United States
Job Summary
Regulatory CMC Manager/Senior Manager to provide regulatory CMC support for small molecules across clinical and commercial programs; drafts Module 2 and Module 3 documents and collects supportive documentation (Letters of Authorization, Certificates of Analysis, Batch Records); participates in CMC regulatory activities to support clinical trials and marketing approvals; represents regulatory on multi-disciplinary CMC product development teams; serves as a resource on regulatory requirements, processes, and logistics for drug development; maintains current knowledge of CDER guidance, MAPPS, and ICH Guidelines; interfaces with CMC vendors; develops and implements SOPs and processes; requires advanced degree with 1–3 years (or BS with 5+ years) Regulatory CMC experience; experience with solid oral dosage forms; based at Axsome HQ in New York City with on-site requirement of at least three days per week.
Required Qualifications
- Master’s or Ph.D. in chemistry or related science preferred with 1–3 years of regulatory CMC experience
- Bachelor’s degree in life science with at least 5 years of Regulatory CMC experience may be considered
Desired Qualifications
- Master’s degree preferred
- Ph.D. degree preferred
- Regulatory CMC experience in Biotechnology or Pharmaceutical industry
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