Regulatory CMC Manager
The Regulatory CMC Manager 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, 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 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
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.
Help Us Achieve Our Mission
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has three approved medicines that treat the underlying cause of cystic fibrosis (CF) – a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational medicines in other serious diseases where it has deep insight into causal human biology, such as sickle cell disease, beta thalassemia, pain, alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy and APOL1-mediated kidney disease.
Founded in 1989 in Cambridge, Mass., Vertex’s global headquarters is now located in Boston’s Innovation District and its international headquarters is in London, UK. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America.
Vertex is consistently recognized as one of the industry’s top places to work, including nine consecutive years on Science magazine’s Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes. For company updates and to learn more about Vertex’s history of innovation visit www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.
The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.
Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
Learn more here
Job posted: 2021-04-26