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better Manager/Sr Manager/Associate Director Regulatory Affairs CMC
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MR - Klein Hersh International-Cambridge, MA, 02142
Manager/Sr Manager/Associate Director Regulatory Affairs CMC Our client is an entrepreneurial pharmaceutical company focused on the development of medicines to target important human needs. They are experiencing significant growth and recently received positive results from a phase III trial for their lead compound. This is a great opportunity to join a company that offers potential for you to leverage your experience and take your career to the next level while working with a world-class drug discovery team. Job Responsibilities: - Responsible for developing and implementing CMC regulatory...
Director Regulatory Affairs Jobs in Cambridge, Massachusetts Jobs
Millennium Pharmaceuticals | Cambridge, MA, 02238, USA | >8
JOB TITLE Dir, Regulatory Affairs Requisition Number 6170BR Department Name Regulatory Therapeutics Location Cambridge, MA POSITION SUMMARY This Director position is established to play a key role in the planning and management of regulatory submissions to global health authorities. This individual is expected to provide leadership within Regulatory Affairs and all other data generating departments to ensure timely filing and approval of assigned oncology programs DUTIES & RESPONSIBILITIES Direct management of assigned oncology programs; driving all submission activities (IND/CTA, trial mai...
InVivo Therapeutics Corporation | Cambridge, MA, 02142 | 10-15
As a medical device startup company, the duties and responsibilities of this position will evolve every day, but the position will have responsibility for leading and supporting our regulatory efforts. Responsibilities may include but are not limited to: · Develop regulatory strategies, systems and processes to ensure that the Company’s development, approval application, registration and commercialization plans meet U.S. and foreign regulatory requirements and company goals. · It is expected that in areas where you are not an expert, such as GMP and foreign regulatory processes, you will re...
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