Director, Regulatory CMC Strategy & Submissions (Hybrid)

Madrigal Pharmaceuticals Inc.; Conshohocken (Montgomery County); Hybrid; USD 207,000 - 253,000; Full time

Benefits offered by this job

Equity

Bonus

401(k)

Job summary

Madrigal Pharmaceuticals Inc. in Waltham, MA is seeking a Director of Regulatory Affairs CMC to provide strategic regulatory CMC leadership for clinical trials, registrations and post-approval activities.

You will lead cross-functional teams and interact with Health Authorities to shape dossier content and submission strategies. The role requires a BS in life sciences with 12+ years in regulatory CMC, including 8-10 years in leadership.

Qualifications

• BS in life sciences or healthcare field; advanced degree preferred.
• 12+ years regulatory CMC experience with 8-10 years in regulatory CMC.
• Strategic regulatory CMC experience with a track record in development, commercialization and lifecycle management of small molecule products.
• Experience interacting with global health authorities on CMC topics.
• Excellent communication and negotiation skills; ability to present scientific cases to SMEs and regulators.

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 challenges during development and commercialization.
• Guides the team in defining and driving the strategy for CMC dossier content and ensures conformance with Health Authority requirements.
• Represents the Madrigal Regulatory CMC function in Health Authority meetings and leads preparation for CMC-related discussions.
• Provides global regulatory input to quality activities, including change controls and investigations.
• Proactively identifies regulatory CMC risks and communicates with line management.
• Monitors global regulatory requirements and emerging trends relevant to CMC.

Skills

Regulatory CMC

Regulatory strategy

Global interactions

Communication skills

Negotiation skills

Education

BS in life sciences

Advanced degree preferred

Job description

Madrigal Pharmaceuticals Inc. in Waltham, MA is seeking a Director of Regulatory Affairs CMC to provide strategic regulatory CMC leadership for clinical trials, registrations and post-approval activities.

You will lead cross-functional teams and interact with Health Authorities to shape dossier content and submission strategies. The role requires a BS in life sciences with 12+ years in regulatory CMC, including 8-10 years in leadership.