Director, Regulatory Affairs CMC
Madrigal Pharmaceuticals
July 01, 2026
Remote friendly (Waltham, MA)
United States
Corporate Functions
Key Responsibilities:
- Independently develop and lead execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
- Apply expert regulatory CMC knowledge to address and overcome challenges during development and commercialization.
- Define and drive strategy for CMC regulatory dossier content; review for conformance with Health Authority requirements.
- Represent Regulatory CMC in Health Authority meetings; drive preparation activities for CMC-related meetings.
- Provide global regulatory input and support to quality-related activities, including regulatory impact assessments for change controls, deviations and investigations.
- Proactively identify regulatory CMC risks and ensure timely communication with line management.
- Monitor, interpret and communicate relevant global CMC regulatory requirements, guidelines, and emerging trends.
Required & Desired Qualifications:
- BS in life sciences in a healthcare field or equivalent experience; advanced degree strongly preferred.
- Minimum 12 years relevant experience; 8–10 years regulatory CMC experience; broad-based CMC technical and product experience.
- Strategic regulatory CMC experience with proven track record in clinical, commercialization, and life cycle management of small molecule products.
- Demonstrated experience interacting with global health authorities on CMC topics.
- Strong knowledge of regulations/guidelines governing global CMC development of pharmaceuticals.
- Excellent communication and proven negotiation skills; ability to communicate with technical SMEs and present a scientific case to internal stakeholders and/or regulatory agencies.
Compensation/Benefits (explicitly stated):
- Base salary estimate: $207,000–$253,000 per year; equity; bonus.
- Full-time benefits: flexible paid time off; medical/dental/vision; life/disability insurance; 401(k) options; additional voluntary benefits (e.g., supplemental life insurance, legal services); mental health benefits via Employee Assistance Program.
Application Instructions:
- Submit applications on an ongoing basis via the Madrigal Careers site.
- Independently develop and lead execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
- Apply expert regulatory CMC knowledge to address and overcome challenges during development and commercialization.
- Define and drive strategy for CMC regulatory dossier content; review for conformance with Health Authority requirements.
- Represent Regulatory CMC in Health Authority meetings; drive preparation activities for CMC-related meetings.
- Provide global regulatory input and support to quality-related activities, including regulatory impact assessments for change controls, deviations and investigations.
- Proactively identify regulatory CMC risks and ensure timely communication with line management.
- Monitor, interpret and communicate relevant global CMC regulatory requirements, guidelines, and emerging trends.
Required & Desired Qualifications:
- BS in life sciences in a healthcare field or equivalent experience; advanced degree strongly preferred.
- Minimum 12 years relevant experience; 8–10 years regulatory CMC experience; broad-based CMC technical and product experience.
- Strategic regulatory CMC experience with proven track record in clinical, commercialization, and life cycle management of small molecule products.
- Demonstrated experience interacting with global health authorities on CMC topics.
- Strong knowledge of regulations/guidelines governing global CMC development of pharmaceuticals.
- Excellent communication and proven negotiation skills; ability to communicate with technical SMEs and present a scientific case to internal stakeholders and/or regulatory agencies.
Compensation/Benefits (explicitly stated):
- Base salary estimate: $207,000–$253,000 per year; equity; bonus.
- Full-time benefits: flexible paid time off; medical/dental/vision; life/disability insurance; 401(k) options; additional voluntary benefits (e.g., supplemental life insurance, legal services); mental health benefits via Employee Assistance Program.
Application Instructions:
- Submit applications on an ongoing basis via the Madrigal Careers site.