Chemistry Manufacturing Controls Manager - 12-month FTC

About the Company
This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community.
Job Description General Summary
The Chemistry Manufacturing Controls Manager will influence the execution of multi-product global regulatory CMC strategies for marketed products. This role contributes to the preparation and submission of regulatory CMC documentation and with interactions with Health Authorities for CMC topics. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into commercial programs.
Key Duties and Responsibilities
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 colleagues in development of global regulatory CMC strategies and submissions
Provides regulatory CMC guidance to cross-functional teams and key stakeholders
Influences regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
Knowledge and Skills
Key Requirements:
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
- Experience in the preparation, including writing, of CMC submissions
- Strategic thinking and strong problem solving skills
- Ability to collaborate and communicate 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
- Sound knowledge of cGMP, FDA, EMA, ICH
Education and Experience
Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field. Extensive experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience is required.
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. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at #####.
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