Regulatory CMC Manager, Cell and Gene Therapy

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • 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.

📋 Description

• Support the execution of cell and gene therapy global regulatory CMC strategies for marketed and development products • Contributes to the preparation and submission of regulatory CMC documentation • 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 • 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 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 • Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

🎯 Requirements

• 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 • Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field

🏖️ Benefits

• 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. • We are committed to building an inclusive culture – where you can authentically be yourself.