Regulatory CMC Manager
Neurocrine Biosciences
July 01, 2026
Remote friendly (San Diego, CA)
United States
Corporate Functions
About The Role
Manages the day-to-day Chemistry, Manufacturing and Controls (CMC) regulatory activities for one or more development and/or marketed projects to impact departmental and company success.
Your Contributions
- Manages several projects simultaneously with an emphasis on CMC while adapting to changing priorities
- Maintains all CMC aspects of US regulatory filings and clinical trial applications outside the US in compliance with applicable regulations and guidelines (domestic/international)
- Assists and provides guidance on writing/editing regulatory submissions per departmental and regulatory standards
- Produces high-quality regulatory submissions for electronic publishing systems
- Researches and analyzes current regulations and guidance
- Expedites review and/or approval of submissions
- Provides CMC regulatory support and expertise to QA, QC, and Manufacturing; develops CMC regulatory strategies including technical documentation and change controls
- Ensures adherence to applicable government regulations
- May communicate with US and international regulatory authorities on specific projects
- Participates in project team meetings and provides regulation-related advice
- Performs assigned project activities and other duties as required
Requirements
- BS/BA in Life/Health Sciences (or related) + 6+ years Regulatory Affairs in a pharmaceutical company, OR Master’s + 4+ years, OR PhD + 2+ years
- Knowledge of best practices; works to improve tools/processes
- Ability to work as part of and lead multiple program teams
- Excellent computer skills; problem-solving and analytical thinking
- Strong project management; cross-functional and independent work; excellent verbal/written communication
- Knowledge of FDA regulations, including current Good Manufacturing Practices
- Experience with eCTD, electronic document management, and document review/approval processes
- Experience managing external contract services and direct interaction with FDA
Manages the day-to-day Chemistry, Manufacturing and Controls (CMC) regulatory activities for one or more development and/or marketed projects to impact departmental and company success.
Your Contributions
- Manages several projects simultaneously with an emphasis on CMC while adapting to changing priorities
- Maintains all CMC aspects of US regulatory filings and clinical trial applications outside the US in compliance with applicable regulations and guidelines (domestic/international)
- Assists and provides guidance on writing/editing regulatory submissions per departmental and regulatory standards
- Produces high-quality regulatory submissions for electronic publishing systems
- Researches and analyzes current regulations and guidance
- Expedites review and/or approval of submissions
- Provides CMC regulatory support and expertise to QA, QC, and Manufacturing; develops CMC regulatory strategies including technical documentation and change controls
- Ensures adherence to applicable government regulations
- May communicate with US and international regulatory authorities on specific projects
- Participates in project team meetings and provides regulation-related advice
- Performs assigned project activities and other duties as required
Requirements
- BS/BA in Life/Health Sciences (or related) + 6+ years Regulatory Affairs in a pharmaceutical company, OR Master’s + 4+ years, OR PhD + 2+ years
- Knowledge of best practices; works to improve tools/processes
- Ability to work as part of and lead multiple program teams
- Excellent computer skills; problem-solving and analytical thinking
- Strong project management; cross-functional and independent work; excellent verbal/written communication
- Knowledge of FDA regulations, including current Good Manufacturing Practices
- Experience with eCTD, electronic document management, and document review/approval processes
- Experience managing external contract services and direct interaction with FDA