Senior Director, Regulatory CMC – Impact & Equity

Madrigal; Waltham (MA); Híbrido; USD 259.000 - 293.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Equity

Flexible paid time off

Medical, dental, vision

Life/disability insurance

401(k) offerings

Supplemental life insurance

Legal services

Mental health benefits

Other benefits

Descripción de la vacante

Madrigal is a biopharmaceutical company focused on therapies for MASH. The Senior Director of Regulatory Affairs CMC provides strategic CMC leadership for clinical trials, registrations, and post-approval activities, leading cross-functional teams to ensure compliance and timely submissions.

You will guide dossier content, interact with Health Authorities, and shape regulatory strategies across development and commercialization while collaborating with QA and regulatory peers.

Formación

• Minimum 15 years’ regulatory CMC experience with broad CMC technical and product experience.
• Strategic regulatory CMC experience across clinical, commercialization and lifecycle 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.
• Able to present a scientific case to SMEs and to regulatory agencies.

Responsabilidades

• Independently develops and leads execution of regulatory CMC strategies for products across lifecycle.
• Applies expert regulatory CMC knowledge to address development and commercialization challenges.
• Guides strategy for CMC dossier content and writes/reviews content for Health Authority conformance.
• Represents Regulatory CMC in Health Authority meetings and prepares meetings on CMC topics.
• Provides global regulatory input to quality activities, inspections, and change controls.
• Identifies regulatory CMC risks and develops mitigation strategies with timely communication.
• Monitors regulatory requirements, guidelines, and emerging trends.

Conocimientos

Regulatory CMC

Regulatory strategy

Global Health Authorities

Cross-functional leadership

Regulatory writing/review

Communication

Negotiation

Educación

BS in life sciences

Advanced degree preferred

Descripción del empleo

Madrigal is a biopharmaceutical company focused on therapies for MASH. The Senior Director of Regulatory Affairs CMC provides strategic CMC leadership for clinical trials, registrations, and post-approval activities, leading cross-functional teams to ensure compliance and timely submissions.

You will guide dossier content, interact with Health Authorities, and shape regulatory strategies across development and commercialization while collaborating with QA and regulatory peers.