Address Job Description
The Manager, Regulatory CMC (Chemistry, Manufacturing, Controls) will influence the execution of multi-product global regulatory CMC strategies for investigational and 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 investigational and 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 investigational and/or 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:
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in regulatory (FDA, EMA, International 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 in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
- Strong experience in the pharmaceutical industry or related field.
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:
1. Hybrid and work remotely up to two days per week; or select
2. On-Site and work 5 days per week with ad hoc flexibility.
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.
