Senior Manager CMC Regulatory Affairs

Job Summary

Providing CMC regulatory strategy expertise, the full-time Senior Manager CMC Regulatory Affairs will ensure compliance for investigational, new, and marketed biologic and small molecule drug products, primarily focusing on the US market while also supporting EU and Canada, all in a remote work environment.

Key responsibilities

• Develop and implement regulatory strategies for CMC-related submissions and post-approval changes
• Prepare and review CMC and GMP documents for regulatory authority submissions, ensuring compliance with standards
• Collaborate with cross-functional teams and represent CMC RA in project meetings to provide regulatory guidance

Required qualifications

• 7 years of CMC regulatory experience in the pharmaceutical industry, with a proven track record of successful investigational filings
• Comprehensive knowledge of CMC regulatory requirements for biologics and small molecules
• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field; advanced degrees preferred
• Experience with INDs, BLAs, and CTAs, including submissions to FDA and equivalent authorities
• Proactive strategic thinker with strong analytical and organizational skills