Principal Scientist, Regulatory CMC

Position Summary

The Principal Scientist, Regulatory CMC (reports to Director, Regulatory CMC) participates in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manages preparation of dossiers in eCTD format.

• Prepare and review Module 2 (QOS) and Module 3 documents per CTD guidances and company standards.
• Contribute to global CMC regulatory strategies.
• Assist with preparation/review of pharmacy manuals, protocols, CMC reports, and other documentation.
• Provide expert opinion on planned/performed CMC topics.
• Contribute to design of CMC protocols.
• Coordinate with other groups on CMC matters.
• Assist with responses to Health Authority CMC comments/questions.
• Train others on Regulatory Affairs SOPs, processes, and templates for document review/preparation/QC/finalization.
• Perform ad‑hoc/cross‑functional duties/projects as assigned.

• BS in life sciences/technical discipline with 10+ years; or MS with 8+ years; or Doctorate with 6+ years.
• Experience preparing CMC modules in eCTD format.
• Familiarity organizing responses to Health Authority requests.

• Familiarity with regulatory submissions outside the US.

• Knowledge of Health Authority procedures/guidance for document management and electronic submission.
• Knowledge of Health Authority CMC guidance/requirements.
• Proficient with Electronic Document Management Systems.
• Ability to meet deadlines; strong communication and attention to detail.
• Biologic-based drugs knowledge (preferred): cell therapies, gene therapies, antibodies, recombinant proteins.

• Medical, dental, and vision plans; EAP; life/AD&D; short- and long-term disability; healthcare/dependent care FSAs; 401(k) match; 529; PTO and paid holidays.

Application Instructions:
Anticipated closure: 60 days from posting (or sooner if filled/closed).