Madrigal Pharmaceuticals

Vice President, Regulatory Affairs, CMC

PA - Conshohocken - Office, USA · Exec · Full-time

Sponsorship not specified$315k-$386kDetected 27 days ago

ExcelOperations ManagementCompensationFDA RegulatoryMentoringMicrosoft OfficeRegulatory 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).

Collaborate on the development and/or optimization of product development strategy to be consistent with regulatory requirements.
Maintain a high level understanding of global regulatory requirements including those for filing and approval of investigational and commercial products.
Develop and implement strategies to proactively influence/address these changes.
Manage budget associated with group activities including submission fees (ex-US), business travel and training.
Provide regulatory support for due diligence activities associated with the assessment of business opportunities.

+20 years of overall relevant experience.
Graduate degree in a scientific/technical discipline (Ph.D., MS Science or PharmD.) with a minimum 12 years pharmaceutical drug development experience and 7 years hands-on regulatory experience.
Proven track record in new chemical entity and line extension regulatory filings, approvals and strategic planning.
Strong knowledge of regulations/guidelines governing development and commercialization of pharmaceuticals.
Experience supporting and conducting due diligence activities.
Strong knowledge of regulations/guidelines governing pharmaceutical/biologics development is required.
Familiarity/understanding of FDA regulatory processes (experience with ex-US regulatory authorities/processes is required)
Ability to communicate clearly and concisely with senior management and regulatory authorities.
Ability to multi-task in a fast-paced atmosphere with multiple/changing priorities.
Ability to effectively delegate tasks and hold others accountable.
Education & Experience
Basic computer skills (MS Office, Excel and Adobe Acrobat).
Knowledge
Skills & Abilities
Experience managing multiple headcount and developing/mentoring junior staff.

Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands.
The base salary range for this position is $315,000 to $386,000 per year.

Our equity offers meaningful opportunity allowing our employees to share in the success they help create.
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.

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.
By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
The company also provides other benefits in accordance with applicable federal, state, and local laws.
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.