Senior Manager, Regulatory Affairs - CMC
Lead the execution of multi-product global regulatory CMC strategies for investigational and marketed products in US, EU, and other International regions. Lead the preparation and filing of regulatory CMC submissions and manage the interactions with Health Authorities for CMC topics.
Provide regulatory support and guidance to various cross-functional teams and ensure all applicable global regulatory requirements are considered and appropriately incorporated into clinical and commercial products.
- Lead the preparation and review of CMC sections of regulatory submissions (IND/IMPD/NDA/MAA), as well as the interactions and responses with regulatory agencies
- Develop global CMC regulatory strategies for one or more late-stage investigational products from Ph3 through initial marketing applications and post-approval lifecycle maintenance
- Collaborate with US & International regulatory colleagues in development of global CMC regulatory strategies and submissions
- Provide CMC regulatory guidance to cross-functional teams and key stakeholders
- Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
- Work effectively on cross-functional teams and be the primary regulatory CMC contact for assigned products and projects
- BA/BS/University degree in Physical/Life/Health Sciences required; advanced degree preferred
- 7+ years of pharmaceutical or biotech industry experience
- 5+ years of regulatory affairs CMC experience (or relevant experience), preferably in Phase 3 or commercialized products
- Strategic thinking and strong problem solving skills
- Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
- Experience in leading the preparation, including writing, CMC submissions
- Strong communication skills, including both written and oral
- A collaborative individual, who listens effectively and invites response and discussion who 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, understanding the scientific principles and regulatory requirements.
- In-depth knowledge of cGMP, FDA, EMA, ICH, global experience in Latin America and other regions a plus.
- Experience with Quality by Design (QbD) filings, post-approval maintenance, change controls, Trackwise and establishment registration requirements
- Understanding of the end-to-end drug development process
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.
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.