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| Assoc Director Reg Affairs MA Open (J#45226) Title: Assoc Director Reg Affairs Company: Genzyme Full Time Description Reporting to the Senior Director, Regulatory Affairs, this position will provide support for Chemistry Manufacturing and Controls (CMC RA) for licensed and clinical products; both small molecule and biological proteins. This position will provide product strategy and direction to commercial and clinical teams. Incumbent will be responsible for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. Incumbent will lead a team of regulatory professionals and be responsible for their development. Experience working in a Matrix environment and excellent people skills are required. Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management. Experience in Biotechnology is required. More... | |||
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