Senior Manager, Regulatory Strategy

Madrigal Pharmaceuticals • Conshohocken, PA

7d • $150,000 - $184,000

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.

Requirements

• BS in life sciences in a healthcare field or equivalent experience, advanced degree strongly preferred.
• Minimum 6 years branded regulatory pharmaceutical drug development, experience, including experience with compilation and filing regulatory submissions
• Strong knowledge of regulations/guidelines governing global development of pharmaceuticals is required.
• Must be able to research and apply regulatory guidance and precedent to programs.
• Excellent verbal and written communication skills.
• Must be able to effectively communicate with scientists at all levels and be able to present a scientific case to effectively communicate within the organization and/or regulatory agencies
• Detail & deadline oriented; well organized
• Good interpersonal skills; ability to interact with staff on all levels
• Strong organizational and demonstrated problem-solving capabilities
• Ability to thrive in a busy environment and maintain a positive attitude under pressure

Nice To Haves

• advanced degree strongly preferred.

Responsibilities

• Works on day-to-day regulatory activities of assigned projects for compounds under development and/or marketed. These activities include supporting the Global Regulatory Lead and acting as a regulatory representative on cross-functional teams, planning regulatory submission strategies, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities.
• Actively participates in the development, creation, and implementation of regulatory and development products by providing regulatory guidance and compliance oversight for regulated products.
• Works collaboratively with regulatory leadership in the development of draft labeling for drug development candidates.
• Participates on cross-functional teams to establish regulatory strategy for developing content for draft package inserts for NDA/BLA submissions.
• Interfaces with various departments within R&D, Commercial and other applicable groups to develop and execute viable Regulatory Strategies in collaboration with the Global Regulatory Lead.
• Develop partnerships both internal and external to the company.
• Accurately assess and convey regulatory risk/opportunities and influence decision makers.
• Responsible for working on the compilation, submission and maintenance of INDs, NDAs, MAAs, CTAs, labeling submissions, amendments, and supplements.
• May serve as a Company contact with FDA.
• In collaboration with the Global Regulatory Lead aids in the preparation for meetings conducted with CDER/CBER, including rehearsals and development of meeting requests and briefing books.
• Monitors the regulatory environment and communicates developments to various stakeholders within the company (clinical, regulatory, senior leadership, etc).
• Applies strong technical regulatory knowledge to advising business functions regarding regulatory requirements to enable successful implementation of business strategies.
• Provides advice and direction regarding scientific and medical issues as related to application of regulations and guidelines for regulated products.

Benefits

• Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package.
• Full-time employees are eligible for base salary, bonus, equity, and a comprehensive benefits suite.
• 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: Mid Level
• Number of Employees: 251-500 employees