Regulatory CMC Manager – Contract

Vertex Pharmaceuticals

Regulatory CMC Manager supporting cell and gene therapy regulatory strategies for Vertex Pharmaceuticals. Involved in regulatory submissions and providing guidance to cross-functional teams.

Posted 6/25/2026contractRemote • 🇺🇸 United StatesMid-LevelSenior💰 $70 - $80 per hourWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory CMCCMC documentationRegulatory submissionsGMP investigationsPost approval variationsRegulatory assessmentChange controlsBiologicsCell and gene therapyStrategic planning

Soft Skills

Interpersonal skillsStrategic thinkingProblem-solvingCollaborationCommunication

Tools & Technologies

FDA guidelinesEMA guidelinesInternational regulatory guidelines

Certifications & Qualifications

Bachelor's degree in BiologyBachelor's degree in ChemistryBachelor's degree in PharmacyBachelor's degree in Regulatory AffairsBachelor's degree in Medical Devices

Industry Keywords

Regulatory CMC strategiesCross-functional teamsRegulatory agenciesCommercial productsProduct compliance

About the role

Key responsibilities & impact

Support the execution of cell and gene therapy regulatory CMC strategies for marketed products
Contributes to the planning, preparation and submission of regulatory CMC documentation
Provides regulatory support and guidance to various cross functional teams
Planning and execution of international regulatory CMC submissions, including creation of content plans
Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
Contributes to the development of global regulatory CMC strategies for commercial products
Works with regulatory and technical colleagues to ensure timely submission and approval of CMC changes in the post approval environment
Provides regulatory CMC guidance to cross-functional teams and key stakeholders
Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Requirements

What you’ll need

Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
5 years of Regulatory CMC experience, preferably in the biologics or cell and gene therapy field
Strong interpersonal skills to exchange complex information with others and to guide others
Proficiency in FDA, EMA and international regulatory guidelines
Experience in the preparation, reviews and submissions of CMC post approval variations
Strong sense of planning, strategic thinking and problem-solving skills
Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
Capable of strategic thinking with ability to resolve complex and ambiguous situations

Benefits

Comp & perks

Eligible for overtime pay in accordance with federal and state requirements