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Regulatory CMC Manager
Vertex Pharmaceuticals. Support execution of multi-product global regulatory CMC for marketed products .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in global regulatory CMC strategies and submissions, particularly for Biologics, while ensuring compliance with FDA, EMA, and Health Canada guidelines. Strong collaboration and communication skills are essential for effective cross-functional teamwork and regulatory interactions.
Highest-signal resume keywords
Regulatory CMC DocumentationBiologics Regulatory SupportFDA Regulatory GuidelinesCGMP KnowledgeCross-Functional Team Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory CMC StrategiesClinical Trial SubmissionsLifecycle Management StrategyRegulatory Submissions ReviewRegulatory Agency Interactions
Soft Skills
Problem-Solving SkillsPlanning and PrioritizationInterpersonal SkillsCommunication Skills
Industry Keywords
Pharmaceutical IndustryBiologicsFDAEMAHealth CanadaICHCGMP
About the role
Key responsibilities & impact- Support execution of multi-product global regulatory CMC for marketed products
- Prepare and submit regulatory CMC documentation, including clinical trial submissions
- Provide regulatory support to cross-functional teams with a focus on Biologics
- Execute commercial Lifecycle Management strategy and submissions focused on US/Canada/Europe
- Review CMC sections of regulatory submissions and interactions and responses with regulatory agencies
- Develop global regulatory CMC strategies and submissions with regulatory colleagues
- Participate on cross-functional teams
- Serve as the primary regulatory CMC contact for assigned products and projects
Requirements
What you’ll need- Bachelor's degree, preferably in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
- Typically requires 4 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience
- Proficiency in FDA, EMA, Health Canada and ICH regulatory guidelines
- Sound knowledge of cGMP, FDA, EMA, ICH
- Strong problem-solving skills
- Strong planning and prioritization skills
- Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
- Ability to work with all levels of management
- Strong interpersonal skills to exchange complex information with others and to guide others
Benefits
Comp & perks- Overtime pay in accordance with federal and state requirements
- Compensation and medical benefits will be presented by the third-party agency partner upon offer
- Fringe benefits and other employment terms will be presented by the third-party agency partner upon offer