Madrigal Pharmaceuticals

Director, Regulatory Affairs CMC

MA - Waltham - Office, USA · Director · Full-time

Sponsorship not specified$207k-$253kDetected 27 days ago

NegotiationCompensationFDA RegulatoryLeadershipCommunicationRegulatory Affairs

About the role

Every member of our Madrigal team is connected by our shared purpose: leading the fight against 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).

Independently develops and leads execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
Provides global regulatory input and support to quality-related activities, including regulatory impact assessments for change controls, deviations and investigations.

Required & Desired Qualifications
Strategic regulatory CMC experience with a proven track record in clinical, commercialization and life cycle management of small molecule products.
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

Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands.
As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $207,000 - $253,000 per year.

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.
BS in life sciences in a healthcare field or equivalent experience, advanced degree strongly preferred.
Demonstrated experience interacting with global health authorities on CMC topics.
Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity.
Our equity offers meaningful opportunity allowing our employees to share in the success they help create.
All employees receive equity, which we believe reinforces our ownership culture.
All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create.
We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings.
In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family.

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.
We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process.

This listing is sourced directly from Madrigal Pharmaceuticals's careers page and normalized into a canonical job model.