Senior Director, Regulatory Affairs CMC
Mirum Pharmaceuticals, Inc.
August 30, 2026
Remote friendly (Foster City, CA)
United States
$280,000 - $310,000 USD yearly
Corporate Functions
Postion Summary
Senior Director, Regulatory Affairs CMC to provide strategic and operational leadership to ensure the effectiveness of the Regulatory Affairs CMC team across the organization. Responsible for all CMC-related submissions (strategic planning, execution, and quality/accurate documents within timelines) and for interpreting/discussing CMC data with cross-functional teams and Health Authorities.
Job Functions/Responsibilities
- Oversee development and implementation of regulatory CMC strategies for market applications, post-marketing CMC commitments, and global development programs.
- Lead regulatory CMC strategy for assigned projects; ensure appropriate execution.
- Develop regulatory positions for assets by tracking corporate planning, business objectives, and current regulatory requirements; incorporate into submission planning.
- Ensure team effectiveness across functions.
- Identify regulatory challenges/risks, lead risk assessments, and oversee change controls.
- Partner with internal/external stakeholders; build and manage relationships.
- Ensure CMC dossiers meet ICH format/content and local country requirements.
- Analyze and exercise judgment on complex CMC issues.
- Support submissions (e.g., NDA/MAA), briefing packages, and Health Authority responses, including annual updates.
- Lead CMC discussions with Health Authorities; strategy experience for small molecules, biologics, and orphan/breakthrough programs.
- Manage direct reports and mentor junior professionals.
Qualifications
- 12+ years in Regulatory Affairs CMC.
- Experience across market applications (NDA/sNDA/MAA/variations), investigational applications (IND/CTA), and commercial lifecycle.
- Advanced degree in relevant scientific discipline required; PhD in chemistry or related field preferred.
- Small molecule and biologics regulatory CMC experience (late-stage through commercialization).
- Combination product experience preferred.
- Successful submissions to FDA and/or other Health Authorities (including EMA); Japan/China exposure plus; other regions/countries a plus.
- Strong ability to apply scientific principles to assess issues, collect/analyze data, and draw conclusions.
- Excellent interpersonal/communication skills; ability to partner/influence.
- Outstanding people management and mentorship; strong planning/organizational skills; comfortable with fast pace and minimal direction.
Travel: 5–10% domestic/international.
Compensation: $280,000–$310,000 USD base salary (bonus/equity/benefits not included unless stated).
Senior Director, Regulatory Affairs CMC to provide strategic and operational leadership to ensure the effectiveness of the Regulatory Affairs CMC team across the organization. Responsible for all CMC-related submissions (strategic planning, execution, and quality/accurate documents within timelines) and for interpreting/discussing CMC data with cross-functional teams and Health Authorities.
Job Functions/Responsibilities
- Oversee development and implementation of regulatory CMC strategies for market applications, post-marketing CMC commitments, and global development programs.
- Lead regulatory CMC strategy for assigned projects; ensure appropriate execution.
- Develop regulatory positions for assets by tracking corporate planning, business objectives, and current regulatory requirements; incorporate into submission planning.
- Ensure team effectiveness across functions.
- Identify regulatory challenges/risks, lead risk assessments, and oversee change controls.
- Partner with internal/external stakeholders; build and manage relationships.
- Ensure CMC dossiers meet ICH format/content and local country requirements.
- Analyze and exercise judgment on complex CMC issues.
- Support submissions (e.g., NDA/MAA), briefing packages, and Health Authority responses, including annual updates.
- Lead CMC discussions with Health Authorities; strategy experience for small molecules, biologics, and orphan/breakthrough programs.
- Manage direct reports and mentor junior professionals.
Qualifications
- 12+ years in Regulatory Affairs CMC.
- Experience across market applications (NDA/sNDA/MAA/variations), investigational applications (IND/CTA), and commercial lifecycle.
- Advanced degree in relevant scientific discipline required; PhD in chemistry or related field preferred.
- Small molecule and biologics regulatory CMC experience (late-stage through commercialization).
- Combination product experience preferred.
- Successful submissions to FDA and/or other Health Authorities (including EMA); Japan/China exposure plus; other regions/countries a plus.
- Strong ability to apply scientific principles to assess issues, collect/analyze data, and draw conclusions.
- Excellent interpersonal/communication skills; ability to partner/influence.
- Outstanding people management and mentorship; strong planning/organizational skills; comfortable with fast pace and minimal direction.
Travel: 5–10% domestic/international.
Compensation: $280,000–$310,000 USD base salary (bonus/equity/benefits not included unless stated).