R&D CMC Regulatory Affairs, Chemical Products Sr. Scientist（CMC薬事）
Core
Develop and manage CMC regulatory submissions for new chemical drug products from development initiation through approval and post-approval changes.
Role type
Senior Regulatory Affairs Scientist (CMC)
Builds
Regulatory submission packages (manufacturing methods, specifications, analytical methods, stability data) for new chemical drug products.
Domain
Pharmaceutical industry, Chemical products, Regulatory Affairs
Required skills
CMC laboratory formulation analysis, Master's degree in Medicine/Pharmacy/Chemistry/Biology, English fluency (TOEIC 700+)
Preferred skills
Practical CMC regulatory experience, Experience communicating with international stakeholders
Responsibilities
Collaborate with US headquarters to advance CMC development stages and create high-quality CMC sections of regulatory submissions; Identify and assess CMC risks and develop mitigation strategies; Provide CMC regulatory information to domestic and international departments; Evaluate CMC change information and execute appropriate regulatory responses; Respond to inquiries from regulatory authorities or during approval reviews; Develop strategic responses for CMC matters in coordination with US or overseas sites via travel or conference calls.