Syneos Health
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.
Regulatory CMC Consultant
November 21
Syneos Health
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.
đź“‹ Description
• support the execution of multi-product global regulatory CMC for marketed products • contribute to the preparation and submission of regulatory CMC documentation • provide regulatory support to various cross functional teams • execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on EU / UK / Swiss • reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies • works with regulatory colleagues in development of global regulatory CMC strategies and submissions • participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
🎯 Requirements
• Bachelor's degree, with a preference 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 • Strong interpersonal skills to exchange complex information with others and to guide others • Proficiency in regulatory (EMA and ICH) guidelines • 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 • Sound knowledge of cGMP, EMA, ICH
🏖️ Benefits
• career development and progression • supportive and engaged line management • technical and therapeutic area training • peer recognition and total rewards program
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