Regulatory CMC Manager
Neurocrine Biosciences
20 days ago
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, impacting departmental and company success.
Your Contributions
- Manages several projects simultaneously with an emphasis on CMC while adapting to changing project priorities
- Maintains CMC aspects of US regulatory filings and clinical trial applications outside the US, ensuring compliance with applicable domestic and international regulations/guidelines
- Assists and guides other departments and submission authors on writing/editing regulatory submissions to departmental/regulatory standards
- Produces high-quality regulatory submissions for electronic publishing systems
- Researches and provides analysis of current regulations and guidance
- Expedites review and/or approval of submissions
- Provides CMC regulatory support, guidance, and expertise to QA, QC, and Manufacturing teams; develops CMC regulatory strategies (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 advises on regulatory matters
- Performs other duties as required
Requirements
- BS/BA in Life/Health Sciences or related field AND 6+ years of Regulatory Affairs experience in a pharmaceutical company OR
- Master’s in Life/Health Sciences or related field AND 4+ years of similar experience OR
- PhD AND 2+ years of similar experience
- Knowledge of best practices in the functional discipline; familiarity with broader business concepts
- Ability to work as part of and lead multiple program teams
- Excellent computer, problem-solving/analytical, and project management skills
- Ability to meet multiple deadlines with accuracy/efficiency
- Excellent verbal and written communication; ability to work independently with minimal direction
- Knowledge of FDA regulations, including current Good Manufacturing Practices
- Experience with eCTD, electronic document management systems, and document review/approval processes
- Experience managing external contract services and direct interaction with FDA
Benefits
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision)
Compensation
- Annual base salary: $132,700.00–$182,000.00; annual bonus target 30% of earned base salary; eligibility for equity-based long-term incentive program
Manages the day-to-day Chemistry, Manufacturing and Controls (CMC) regulatory activities for one or more development and/or marketed projects, impacting departmental and company success.
Your Contributions
- Manages several projects simultaneously with an emphasis on CMC while adapting to changing project priorities
- Maintains CMC aspects of US regulatory filings and clinical trial applications outside the US, ensuring compliance with applicable domestic and international regulations/guidelines
- Assists and guides other departments and submission authors on writing/editing regulatory submissions to departmental/regulatory standards
- Produces high-quality regulatory submissions for electronic publishing systems
- Researches and provides analysis of current regulations and guidance
- Expedites review and/or approval of submissions
- Provides CMC regulatory support, guidance, and expertise to QA, QC, and Manufacturing teams; develops CMC regulatory strategies (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 advises on regulatory matters
- Performs other duties as required
Requirements
- BS/BA in Life/Health Sciences or related field AND 6+ years of Regulatory Affairs experience in a pharmaceutical company OR
- Master’s in Life/Health Sciences or related field AND 4+ years of similar experience OR
- PhD AND 2+ years of similar experience
- Knowledge of best practices in the functional discipline; familiarity with broader business concepts
- Ability to work as part of and lead multiple program teams
- Excellent computer, problem-solving/analytical, and project management skills
- Ability to meet multiple deadlines with accuracy/efficiency
- Excellent verbal and written communication; ability to work independently with minimal direction
- Knowledge of FDA regulations, including current Good Manufacturing Practices
- Experience with eCTD, electronic document management systems, and document review/approval processes
- Experience managing external contract services and direct interaction with FDA
Benefits
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision)
Compensation
- Annual base salary: $132,700.00–$182,000.00; annual bonus target 30% of earned base salary; eligibility for equity-based long-term incentive program