Director, Regulatory Affairs CMC
Madrigal Pharmaceuticals
August 13, 2026
Remote friendly (Waltham, MA)
United States
Corporate Functions
Key Responsibilities
- Independently develops and leads execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
- Applies expert regulatory CMC knowledge to address and overcome challenges that arise during development and commercialization.
- Guides the team in defining and driving the strategy for CMC regulatory dossier content and reviews for conformance with established Health Authority requirements.
- Represents the Regulatory CMC function in Health Authority meetings and drives preparation for CMC-related meeting activities.
- Provides global regulatory input and support to quality-related activities, including regulatory impact assessments for change controls, deviations and investigations.
- Proactively identifies regulatory CMC risks and ensures timely communication with line management.
- Monitors, interprets, and communicates relevant CMC-related global 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, including 8–10 years regulatory CMC experience; broad-based CMC technical and product experience.
- Strategic regulatory CMC experience with a 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 present a scientific case to technical SMEs and to internal stakeholders/regulatory agencies.
Application Instructions
- Submit ongoing applications through the Madrigal Careers site.
- Independently develops and leads execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
- Applies expert regulatory CMC knowledge to address and overcome challenges that arise during development and commercialization.
- Guides the team in defining and driving the strategy for CMC regulatory dossier content and reviews for conformance with established Health Authority requirements.
- Represents the Regulatory CMC function in Health Authority meetings and drives preparation for CMC-related meeting activities.
- Provides global regulatory input and support to quality-related activities, including regulatory impact assessments for change controls, deviations and investigations.
- Proactively identifies regulatory CMC risks and ensures timely communication with line management.
- Monitors, interprets, and communicates relevant CMC-related global 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, including 8–10 years regulatory CMC experience; broad-based CMC technical and product experience.
- Strategic regulatory CMC experience with a 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 present a scientific case to technical SMEs and to internal stakeholders/regulatory agencies.
Application Instructions
- Submit ongoing applications through the Madrigal Careers site.