Senior Manager, Regulatory CMC, Cell & Gene Therapy

Job Description

Find out more about this role by reading the information below, then apply to be considered.

General Summary :

The Chemistry Manufacturing Controls Senior Manager will participate in the execution of multi-product global regulatory CMC strategies for investigational and marketed products.

This role leads the preparation and submission of regulatory CMC documentation and manages interactions with Health Authorities for CMC topics.

This role also acts as a resource for regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs.

Key Duties and Responsibilities :

• Prepares and reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
• Develops global regulatory CMC strategies for investigational and / or commercial products.
• Collaborates with regulatory colleagues in development of global regulatory CMC strategies and submissions.
• Provides regulatory CMC guidance in complex situations to cross-functional teams and key stakeholders.
• Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
• Collaborates effectively on cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects.

Knowledge and Skills :

• Proficiency in effective interpersonal skills to explain difficult information and build consensus.
• Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines.
• Proficiency in leading the preparation, including writing, of CMC submissions.
• Strategic thinking and strong problem-solving skills.
• Collaborates and communicates in an open, clear, complete, timely and consistent manner.
• Strong sense of planning and prioritization, and the ability to work with all levels of management.
• Capable of strategic thinking with ability to resolve complex and ambiguous situations.
• In-depth knowledge of cGMP, FDA, EMA, and ICH.

Education and Experience :

• Bachelor's Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field.
• Typically requires 6 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience.

Flex Designation :

Hybrid-Eligible Or On-Site Eligible

Company Information :

Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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