Syneos Health
10,000+ employees
𧏠Biotechnology
đ Pharmaceuticals
âïž Healthcare Insurance
Biotechnology âą Pharmaceuticals âą Healthcare Insurance
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
Regulatory CMC Manager, Cell and Gene Therapy
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đ„ 6 minutes ago
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Syneos Health
10,000+ employees
𧏠Biotechnology
đ Pharmaceuticals
âïž Healthcare Insurance
Biotechnology âą Pharmaceuticals âą Healthcare Insurance
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
đ Description
âą Support the execution of cell and gene therapy global regulatory CMC strategies for marketed and development products âą Contributes to the preparation and submission of regulatory CMC documentation âą Provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs âą Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies âą Contributes to the development of global regulatory CMC strategies for commercial products âą Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions âą Provides regulatory CMC guidance to cross-functional teams and key stakeholders âą Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
đŻ Requirements
âą Strong interpersonal skills to exchange complex information with others and to guide others âą Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines âą Experience in the preparation, including writing, of CMC submissions âą Strategic thinking and strong problem solving skills âą Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner âą Strong sense of planning and prioritization, and the ability to work with all levels of management âą Capable of strategic thinking with ability to resolve complex and ambiguous situations âą Sound knowledge of cGMP, FDA, EMA, ICH âą Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
đïž Benefits
âą We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. âą We are committed to building an inclusive culture â where you can authentically be yourself.
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