Director, Regulatory Strategy

Madrigal Pharmaceuticals • Waltham, MA

4d • Onsite

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. Manages the day-to-day regulatory activities of assigned projects for compounds under development and/or marketed. These activities include acting as the regulatory representative on core teams, developing and planning regulatory submission strategies, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities. Actively participates on Project Teams in the development, creation, and implementation of regulatory and development products by providing regulatory guidance and compliance oversight for regulated products. Works collaboratively with Project Teams 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 submissions. Interfaces with various departments within R&D, Commercial and other applicable groups to develop and execute viable Regulatory Strategies. Demonstrate leadership in developing partnerships both internal and external to the company. Accurately assess and convey regulatory risk/opportunities and influence decision makers. Responsible for managing the compilation, submission and maintenance of INDs, NDAs, MAAs, CTAs, amendments, and supplements. Support and participate in the Company’s due diligence activities in evaluating potential products for acquisition/in-licensing/joint development opportunities. Facilitates the regulatory strategy and serves as a Company contact with FDA and ex-US regulatory agencies. Liaise with the FDA review divisions and represent Regulatory at FDA meetings (e.g. pre-IND, EOP2, Pre-NDA) and with global health authorities and development partners as appropriate for their projects. Leads the preparation for meetings conducted with CDER, 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 expert leadership, advice, and direction regarding scientific and medical issues as related to application of the FDA and other regulatory requirements for regulated products. Deploys Liaison staff to effectively, efficiently, and collaboratively support business requirements ensuring regulatory compliance for development and marketed products.

Requirements

• BS in life sciences in a healthcare field or equivalent experience, advanced degree strongly preferred. (advanced degree a plus)
• Minimum 10 years branded regulatory pharmaceutical drug development experience.
• Broad based therapeutic area and product experience.
• Strategic regulatory affairs experience with a proven track record in new chemical entity and line extension regulatory filings, approvals and strategic planning.
• Demonstrated experience supporting and conducting due diligence activities.
• Demonstrated experience interacting with global health authorities.
• Strong knowledge of regulations/guidelines governing global development of pharmaceuticals is required.
• Excellent communication skills and proven negotiation 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
• Strong preference for candidates to be onsite in either Conshohocken, PA or Waltham, MA.

Nice To Haves

• advanced degree a plus

Responsibilities

• Manages the day-to-day regulatory activities of assigned projects for compounds under development and/or marketed.
• Acts as the regulatory representative on core teams, developing and planning regulatory submission strategies, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities.
• Actively participates on Project Teams in the development, creation, and implementation of regulatory and development products by providing regulatory guidance and compliance oversight for regulated products.
• Works collaboratively with Project Teams 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 submissions.
• Interfaces with various departments within R&D, Commercial and other applicable groups to develop and execute viable Regulatory Strategies.
• Demonstrate leadership in developing partnerships both internal and external to the company.
• Accurately assess and convey regulatory risk/opportunities and influence decision makers.
• Responsible for managing the compilation, submission and maintenance of INDs, NDAs, MAAs, CTAs, amendments, and supplements.
• Support and participate in the Company’s due diligence activities in evaluating potential products for acquisition/in-licensing/joint development opportunities.
• Facilitates the regulatory strategy and serves as a Company contact with FDA and ex-US regulatory agencies.
• Liaise with the FDA review divisions and represent Regulatory at FDA meetings (e.g. pre-IND, EOP2, Pre-NDA) and with global health authorities and development partners as appropriate for their projects.
• Leads the preparation for meetings conducted with CDER, 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 expert leadership, advice, and direction regarding scientific and medical issues as related to application of the FDA and other regulatory requirements for regulated products.
• Deploys Liaison staff to effectively, efficiently, and collaboratively support business requirements ensuring regulatory compliance for development and marketed products.

Benefits

• equity
• flexible paid time off
• medical, dental, vision and life/disability insurance
• 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans
• supplemental life insurance, legal services, and other offerings
• mental health benefits through our Employee Assistance Program for employees and their family

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 501-1,000 employees