Senior Manager, Regulatory CMC at Vertex Pharmaceuticals
Boston, MA 02108
About the Job
Job DescriptionGeneral Summary:The Chemistry Manufacturing Controls Senior Manager will participate in the execution of multi-product global regulatory CMC strategies for investigational and marketed products
This role leads the preparation and submission of regulatory CMC documentation and manages interactions with Health Authorities for CMC topics
This role also acts as a resource for 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:Prepares and reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agenciesDevelops global regulatory CMC strategies for investigational and/or commercial productsCollaborates with regulatory colleagues in development of global regulatory CMC strategies and submissionsProvides regulatory CMC guidance in complex situations to cross-functional teams and key stakeholdersManages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigationsCollaborates effectively on cross -functional teams and acts as the primary regulatory CMC contact for assigned products and projectsKnowledge and Skills:Proficiency in effective interpersonal skills to explain difficult information and build consensusProficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelinesProficiency in leading the preparation, including writing, of CMC submissionsStrategic thinking and strong problem solving skillsCollaborates and communicates in an open, clear, complete, timely and consistent mannerStrong sense of planning and prioritization, and the ability to work with all levels of managementCapable of strategic thinking with ability to resolve complex and ambiguous situationsIn-depth knowledge of cGMP, FDA, EMA, and ICHEducation and Experience:Bachelor's or Master's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science fieldTypically requires 6 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experienceWe’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 select2. On-Site and work 5 days per week with ad hoc flexibility. #LI-AR1 #LI-HybridFlex Designation:Hybrid-Eligible Or On-Site EligibleFlex 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 select2. 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 InformationVertex 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
This role leads the preparation and submission of regulatory CMC documentation and manages interactions with Health Authorities for CMC topics
This role also acts as a resource for 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:Prepares and reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agenciesDevelops global regulatory CMC strategies for investigational and/or commercial productsCollaborates with regulatory colleagues in development of global regulatory CMC strategies and submissionsProvides regulatory CMC guidance in complex situations to cross-functional teams and key stakeholdersManages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigationsCollaborates effectively on cross -functional teams and acts as the primary regulatory CMC contact for assigned products and projectsKnowledge and Skills:Proficiency in effective interpersonal skills to explain difficult information and build consensusProficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelinesProficiency in leading the preparation, including writing, of CMC submissionsStrategic thinking and strong problem solving skillsCollaborates and communicates in an open, clear, complete, timely and consistent mannerStrong sense of planning and prioritization, and the ability to work with all levels of managementCapable of strategic thinking with ability to resolve complex and ambiguous situationsIn-depth knowledge of cGMP, FDA, EMA, and ICHEducation and Experience:Bachelor's or Master's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science fieldTypically requires 6 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experienceWe’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 select2. On-Site and work 5 days per week with ad hoc flexibility. #LI-AR1 #LI-HybridFlex Designation:Hybrid-Eligible Or On-Site EligibleFlex 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 select2. 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 InformationVertex 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.comSummaryLocati
on: Boston, MAType: Full time 