This Job Vacancy has Expired!

Associate Director, Regulatory Affairs

Posted on Apr 19, 2021 by Vertex Pharmaceuticals

Boston, MA 02297
Research
Immediate Start
Annual Salary
Full-Time


Job Description


The Associate Director, Regulatory CMC executes multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics. This role also provides regulatory guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial products. This role may supervise other regulatory staff.


Responsibilities:


Leads the preparation and review of CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies


Develops global CMC regulatory strategies for one or more investigational and/or marketed products


Leads regulatory colleagues in development of global CMC regulatory strategies and submissions


Provides CMC regulatory guidance to cross-functional teams and key stakeholders


Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations


Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects


Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise


Requirements:


Bachelors, Masters or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field


Typically requires 8 years of experience in the pharmaceutical or biotech industry or in a related field, or the equivalent combination of education and experience


Excellent interpersonal skills to communicate difficult concepts and persuade others


Strategic thinking and strong problem-solving skills


Collaborates and 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


Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines




Reference: 1171167877

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