Senior Director, Regulatory Affairs CMC

Madrigal Pharmaceuticals

. Develop and lead execution of regulatory CMC strategies for products in the investigational, registration and/or post-approval lifecycle .

Posted 9/18/2026full-timeWaltham • Massachusetts • United StatesSenior💰 $258,827 - $293,479 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in developing and executing regulatory CMC strategies throughout the product lifecycle, with a strong focus on compliance with Health Authority requirements and effective communication with cross-functional teams and regulatory agencies.

Highest-signal resume keywords

Regulatory CMC Strategy DevelopmentHealth Authority InteractionCMC Dossier Content StrategyRegulatory Compliance KnowledgeRisk Mitigation Strategy

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory CMC ExperienceCMC Technical KnowledgeClinical Development ExperienceCommercialization ExperienceLife Cycle ManagementRegulatory Submission PlanningRegulatory Intelligence ActivitiesChange Control AssessmentsDeviation InvestigationsGlobal Regulatory Requirements

Soft Skills

Excellent Communication SkillsProven Negotiation SkillsAbility to Present Scientific Cases

Industry Keywords

Pharmaceutical RegulationsHealth Authority GuidelinesGlobal CMC DevelopmentInvestigational ProductsPost-Approval Lifecycle

About the role

Key responsibilities & impact

Develop and lead execution of regulatory CMC strategies for products in the investigational, registration and/or post-approval lifecycle
Apply expert regulatory CMC knowledge to address challenges during development and commercialization
Guide the team in defining and driving regulatory CMC dossier content strategy
Write and/or review regulatory CMC dossier content for conformance with Health Authority requirements
Represent Madrigal Regulatory CMC in Health Authority meetings
Drive preparation for Health Authority meetings on CMC-related topics
Provide global regulatory input and support to quality-related activities, including inspections and regulatory impact assessments for change controls, deviations and investigations
Identify regulatory CMC risks and develop mitigation strategies
Communicate risks and strategies to line management
Monitor, interpret and communicate global CMC-related regulatory requirements, guidelines and emerging trends
Act as a regulatory CMC representative on cross-functional teams
Plan regulatory CMC submission strategies
Conduct regulatory CMC intelligence activities
Manage day-to-day regulatory CMC activities for assigned development and/or commercial products

Requirements

What you’ll need

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
Ability to effectively communicate with technical SMEs at all levels
Ability to present a scientific case effectively within the organization and/or to regulatory agencies
Ability to work in the office 3 days per week

Benefits

Comp & perks

Equity for all employees
Flexible paid time off
Medical insurance
Dental insurance
Vision insurance
Life/disability insurance
401(k) offerings, including traditional, Roth, and employer match
Supplemental life insurance
Legal services
Mental health benefits through the Employee Assistance Program for employees and their family
Reasonable accommodations throughout the hiring process