Chemistry Manufacturing Controls Manager

Job Description

General Summary:

The Regulatory Affairs Chemistry Manufacturing Controls (CMC) Manager will influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products. The scope of this role includes leading and managing a specific product's life cycle including post approval variations and line extensions within approved markets and global expansion in new markets. This role contributes to the preparation and submission of regulatory CMC documentation and 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 intothe life cycle of investigational and commercial programs.

Key Duties and Responsibilities:

• Lead team to author, review and approve 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 investigational and/or commercial products
• 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 serve as the global regulatory CMC lead for assigned products and projects

Knowledge and Skills:

• Strong interpersonal skills to exchange complex information with others and to guide others
• Proficiency in global regulatory guidelines (FDA, EMA, Health Canada and ICH)
• 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
• Experience using the Veeva Vault Regulatory Information Management System (RIM)

Education and Experience:

• Bachelor's degree 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

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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 ApplicationAssistance@vrtx.com