Senior Director, Regulatory Affairs CMC
Mirum Pharmaceuticals, Inc.
June 25, 2026
Remote friendly (Foster City, CA)
United States
$280,000 - $310,000 USD yearly
Corporate Functions
Postion Summary
The Senior Director, Regulatory Affairs CMC provides strategic and operational leadership to ensure the effectiveness of the Regulatory Affairs CMC team across the organization. Responsible for CMC-related submissions, including strategic planning, execution, and submission of quality/accurate supporting documents within agreed timelines. Must interpret and discuss 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 and ensure appropriate execution.
- Develop regulatory positions by incorporating corporate planning, business objectives, and current regulatory requirements into submission planning.
- Ensure team effectiveness in developing submissions and partnering across functions.
- Identify regulatory challenges/risks, lead risk assessments, and oversee change controls.
- Partner with internal and external stakeholders; manage key relationships.
- Ensure CMC dossiers meet ICH format/content and applicable local country requirements.
- Analyze complex issues and exercise judgment based on CMC expertise.
- Support regulatory submissions (NDA, MAA, etc.), briefing packages, response documents, and annual updates (e.g., IB, NDA ARs, IND ARs).
- Lead CMC discussions with Health Authorities; provide strategy for small molecule, biologics, and orphan/breakthrough programs.
- Manage direct reports and mentor junior professionals.
Qualifications
- Minimum 12 years of Regulatory Affairs CMC experience.
- Drug development experience across market applications (NDA/sNDA/MAA/variations), investigational applications (INDs/CTAs), and commercial lifecycle.
- Advanced degree in a relevant scientific discipline required; PhD in chemistry (or relevant field) preferred.
- Experience with small molecules and biologics CMC activities through late-stage development/commercialization.
- Combination product experience/knowledge preferred.
- Successful submissions to FDA and/or other Health Authorities (including EMA); exposure to Japan and China a plus; other regions/countries a plus.
- Ability to apply scientific principles to assess regulatory issues, collect/analyze information, and draw valid conclusions.
- Excellent interpersonal, verbal, and written communication; strong partnering/influencing skills.
- Outstanding people management and mentorship skills.
- Strong planning/organization; ability to manage multiple projects with tight timelines.
- Comfortable in a fast-paced, small-company environment with minimal direction.
Work Environment
- High-growth, fast-paced; productive team player; work under minimal supervision.
- Travel 5–10% domestically and internationally.
Compensation
- Salary range: $280,000–$310,000 USD.
Application instructions
- Not provided.
The Senior Director, Regulatory Affairs CMC provides strategic and operational leadership to ensure the effectiveness of the Regulatory Affairs CMC team across the organization. Responsible for CMC-related submissions, including strategic planning, execution, and submission of quality/accurate supporting documents within agreed timelines. Must interpret and discuss 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 and ensure appropriate execution.
- Develop regulatory positions by incorporating corporate planning, business objectives, and current regulatory requirements into submission planning.
- Ensure team effectiveness in developing submissions and partnering across functions.
- Identify regulatory challenges/risks, lead risk assessments, and oversee change controls.
- Partner with internal and external stakeholders; manage key relationships.
- Ensure CMC dossiers meet ICH format/content and applicable local country requirements.
- Analyze complex issues and exercise judgment based on CMC expertise.
- Support regulatory submissions (NDA, MAA, etc.), briefing packages, response documents, and annual updates (e.g., IB, NDA ARs, IND ARs).
- Lead CMC discussions with Health Authorities; provide strategy for small molecule, biologics, and orphan/breakthrough programs.
- Manage direct reports and mentor junior professionals.
Qualifications
- Minimum 12 years of Regulatory Affairs CMC experience.
- Drug development experience across market applications (NDA/sNDA/MAA/variations), investigational applications (INDs/CTAs), and commercial lifecycle.
- Advanced degree in a relevant scientific discipline required; PhD in chemistry (or relevant field) preferred.
- Experience with small molecules and biologics CMC activities through late-stage development/commercialization.
- Combination product experience/knowledge preferred.
- Successful submissions to FDA and/or other Health Authorities (including EMA); exposure to Japan and China a plus; other regions/countries a plus.
- Ability to apply scientific principles to assess regulatory issues, collect/analyze information, and draw valid conclusions.
- Excellent interpersonal, verbal, and written communication; strong partnering/influencing skills.
- Outstanding people management and mentorship skills.
- Strong planning/organization; ability to manage multiple projects with tight timelines.
- Comfortable in a fast-paced, small-company environment with minimal direction.
Work Environment
- High-growth, fast-paced; productive team player; work under minimal supervision.
- Travel 5–10% domestically and internationally.
Compensation
- Salary range: $280,000–$310,000 USD.
Application instructions
- Not provided.