Senior Director, Regulatory CMC Strategy & Submissions

Regulatory Jobs; Waltham (MA); Híbrido; USD 207.000 - 253.000; Tempo integral

Resumo da vaga

Madrigal is seeking a Director of Regulatory Affairs (CMC) to lead regulatory CMC strategies for clinical and commercial products. This role drives global submissions, interfaces with Health Authorities, and partners across functions to ensure compliant, timely development and lifecycle management.

The position requires 12+ years in regulatory CMC with 8–10 years of hands-on experience, plus strong communication and negotiation skills.

Qualificações

• BS in life sciences in a healthcare field or equivalent experience; advanced degree strongly preferred.
• Minimum of 12 years relevant experience with 8–10 years regulatory CMC experience and broad-based CMC technical/product experience.
• Strategic regulatory CMC experience with a 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 negotiation skills; able to present a scientific case to SMEs.
• Hybrid opportunity (3 days per week in office) based in our Waltham, MA is required.

Responsabilidades

• 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 during development and commercialization.
• Guides the team in defining and driving the strategy for CMC regulatory dossier content and reviews it for conformance with Health Authority requirements.
• Represents Madrigal Regulatory CMC in Health Authority meetings and drives preparation activities for meetings on CMC topics.
• 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, ensuring timely communication with line management.
• Monitors, interprets and communicates relevant CMC-related global regulatory requirements, guidelines and emerging trends.

Conhecimentos

Strategic CMC leadership

Global regulatory knowledge

Communication and negotiation

Cross-functional collaboration

Health Authority liaison

Formação

BS in life sciences

Advanced degree preferred

Descrição da vaga

Madrigal is seeking a Director of Regulatory Affairs (CMC) to lead regulatory CMC strategies for clinical and commercial products. This role drives global submissions, interfaces with Health Authorities, and partners across functions to ensure compliant, timely development and lifecycle management.

The position requires 12+ years in regulatory CMC with 8–10 years of hands-on experience, plus strong communication and negotiation skills.