Senior Director, Regulatory Affairs CMC
Madrigal Pharmaceuticals
Summary
The Senior Director of Regulatory Affairs CMC provides highly strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions, along with managing the day-to-day regulatory CMC activities of assigned projects for development and/or commercial products. These activities include acting as a regulatory CMC representative on cross-functions teams, planning regulatory CMC submission strategies, and conducting regulatory CMC intelligence activities.
Job description
Key Responsibilities
- Independently develops and leads execution of regulatory CMC strategies for products in the investigational, registration and/or post-approval lifecycle.
- Applies expert regulatory CMC knowledge to address and overcome challenges that arise during development and commercialization.
- Guides the team in defining and driving the strategy for CMC regulatory dossier content and then writes and/or reviews this content for conformance with established Health Authority requirements.
- Represents the Madrigal Regulatory CMC function in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC-related topics.
- Provides global regulatory input and support to quality-related activities, including inspections and regulatory impact assessments for change controls, deviations and investigations.
- Proactively identifies regulatory CMC risks and develops mitigation strategies, ensuring timely communication with line management.
- Monitors, interprets and communicates relevant CMC-related global regulatory requirements, guidelines and emerging trends.
Required & Desired Qualifications
- BS in life sciences in a healthcare field or equivalent experience, advanced degree strongly preferred.
- Minimum 15 years' regulatory CMC experience, along with broad-based CMC technical and product experience.
- Strategic regulatory CMC experience with a proven track record in clinical, commercialization and life cycle management of small molecule products is required.
- Demonstrated experience interacting with global Health Authorities on CMC topics.
- Strong knowledge of regulations/guidelines governing global CMC development of pharmaceuticals is required.
- Excellent communication skills and proven negotiation skills.
- Must be able to effectively communicate with technical SMEs at all levels and be able to present a scientific case to effectively communicate within the organization and/or regulatory agencies.
Hybrid opportunity (3 days per week in office required) based in our Waltham, MA or Conshohocken, PA offices.
Requirements
- BS in life sciences in a healthcare field or equivalent experience
- Advanced degree strongly preferred
- Minimum 15 years' regulatory CMC experience
- Broad-based CMC technical and product experience
- Strategic regulatory CMC experience with a proven track record in clinical, commercialization and life cycle management of small molecule products
- Demonstrated experience interacting with global Health Authorities on CMC topics
- Strong knowledge of regulations/guidelines governing global CMC development of pharmaceuticals
- Excellent communication skills
- Proven negotiation skills
- Must be able to effectively communicate with technical SMEs at all levels
- Must be able to present a scientific case to effectively communicate within the organization and/or regulatory agencies
Benefits
- Bonus
- Equity
- Flexible paid time off
- Medical, Dental & Vision
- Life/Disability Insurance
- 401(k) with employer match
- Mental health benefits
- Employee Assistance Program
- Supplemental life insurance
- Legal services
Company overview
Madrigal Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH), a serious form of fatty liver disease. The company's lead product, Rezdiffra (resmetirom), is a once-daily, oral thyroid hormone receptor (THR)-β selective agonist that targets key underlying causes of MASH in the liver. Rezdiffra received FDA approval in 2024 as the first treatment for MASH with moderate to advanced liver fibrosis, representing a significant breakthrough in hepatology. Headquartered in Conshohocken, Pennsylvania, Madrigal is publicly traded on NASDAQ under the symbol MDGL. The company continues to advance its clinical development programs, including ongoing Phase 3 trials evaluating Rezdiffra for the treatment of compensated MASH cirrhosis. Madrigal's innovative approach addresses a critical unmet medical need in liver disease therapeutics.