Director, Regulatory Affairs CMC

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 then reviews this content for conformance with established Health Authority requirements.
• Represents the Madrigal Regulatory CMC function in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC-related 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.
• Maintains awareness of 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 of 12 years relevant experience and 8-10 years’ regulatory CMC experience, along with 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 is required.
• Excellent communication skills and proven negotiation skills.
• Must be able to effectively communicate with technical SMEs at all levels and be able to present a scientific case to effectively communicate within the organization and/or regulatory agencies.