Vice President, Regulatory Affairs, CMC

Madrigal Pharmaceuticals • Conshohocken, PA

1d

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. Management of regulatory activities for all projects assigned to the Regulatory CMC group. Ensure regulatory conformance for commercial products through effective change management. Maintain a high level understanding of global regulatory requirements and anticipate the impact of the changing regulatory environment on development and registration strategy. Manage budget associated with group activities and provide regulatory strategy for life-cycle management. Provide regulatory support for due diligence activities associated with the assessment of business opportunities.

Requirements

• +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.
• Basic computer skills (MS Office, Excel and Adobe Acrobat).
• 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.
• Experience managing multiple headcount and developing/mentoring junior staff.
• Ability to effectively delegate tasks and hold others accountable.
• Occasional business travel.

Responsibilities

• Management of all regulatory activities for development and commercial projects assigned to the group: Act or assign a regulatory representative for each project team.
• Oversee the development and implementation of regulatory submission strategy.
• Manage the planning, preparation and technical review of regulatory submissions and ensure submissions are completed to meet required/established timelines.
• Collaborate on the development and/or optimization of product development strategy to be consistent with regulatory requirements.
• Interact with regulatory authorities to address regulatory strategy, milestone meetings, queries and regulatory actions.
• Maintain a high level understanding of global regulatory requirements including those for filing and approval of investigational and commercial products.
• Provide regulatory guidance and strategy for life-cycle management planning and development for commercial products.
• Anticipate the impact of the changing regulatory environment on development plans and registration strategy.
• Develop and implement strategies to proactively influence/address these changes.
• Ensure regulatory conformance for commercial products through effective change management.
• 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.

Benefits

• 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.
• By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
• Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans.
• 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.
• The company also provides other benefits in accordance with applicable federal, state, and local laws.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees