Senior Director, Regulatory Affairs CMC

Madrigal Pharmaceuticals•Conshohocken, PA

1d•$258,827 - $293,479•Hybrid

About The Position

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. The Senior Director of Regulatory Affairs CMC provides highly 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 15 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 is required.
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 strategies for products in the investigational, registration and/or post-approval lifecycle.
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 writes and/or 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 inspections and regulatory impact assessments for change controls, deviations and investigations.
Proactively identifies regulatory CMC risks and develops mitigation strategies, ensuring timely communication with line management.
Monitors, interprets and communicates relevant CMC-related global regulatory requirements, guidelines and emerging trends.