Madrigal Pharmaceuticals · 12 hours ago
Director, Regulatory Strategy
Waltham, MA
Full-time
Onsite
Director/Executive
10+ years expMadrigal Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative treatments for metabolic dysfunction-associated steatohepatitis (MASH). The Director of Regulatory Strategy will manage regulatory activities for development projects, provide guidance on regulatory submissions, and collaborate with various teams to ensure compliance and strategic planning.
BiopharmaBiotechnologyMedical DevicePharmaceutical
Responsibilities
Manages the day-to-day regulatory activities of assigned projects for compounds under development and/or marketed
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
Interfaces with various departments within R&D, Commercial and other applicable groups to develop and execute viable Regulatory Strategies
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
Qualification
Required
BS in life sciences in a healthcare field or equivalent experience, advanced degree strongly preferred
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
Preferred
Strong preference for candidates to be onsite in either Conshohocken, PA or Waltham, MA
Benefits
Flexible paid time off
Medical
Dental
Vision and life/disability insurance
401(k) offerings (i.e., traditional, Roth, and employer match)
Supplemental life insurance
Legal services
Mental health benefits through our Employee Assistance Program for employees and their family
Company
Madrigal Pharmaceuticals
Madrigal Pharmaceuticals is a biopharmaceutical company developing therapeutics for the treatment of cardiovascular-metabolic diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.94BKey Investors
Blue OwlHercules Capital
2025-07-22Post Ipo Debt· $350M
2024-03-18Post Ipo Equity· $690M
2023-09-28Post Ipo Equity· $500M
Leadership Team
Mardi C. Dier
Chief Financial Officer
Carole Huntsman
Chief Commercial Officer (CCO)
Recent News
2026-01-19
Company data provided by crunchbase