Director, Regulatory Affairs CMC

Madrigal Pharmaceuticals•Waltham, MA

1d•$207,000 - $253,000

About The Position

This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions, along with managing the day-to-day regulatory CMC activities of assigned projects for development and/or commercial products. These activities include acting as a regulatory CMC representative on cross-functions teams, planning regulatory CMC submission strategies, and conducting regulatory CMC intelligence activities.

Requirements

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.

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.
Monitors, interprets and communicates relevant CMC-related global regulatory requirements, guidelines and emerging trends.