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MR - Klein Hersh International-Cambridge, MA, 02142
Senior Associate/ Associate, Regulatory Operations 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: - Assist with the development and implementation of systems and proced...
Regulatory Affairs Associate Jobs in Cambridge, Massachusetts Jobs
Ironwood Pharmaceuticals, Inc. | Cambridge, MA, 02141 | 6
Associate/Senior Associate, Regulatory Operations Job Code: JFRA Functional area: Clinical, Biometric and Regulatory Affairs To apply, send email with a subject of “Job Code JFRA” to careers@ironwoodpharma.com. Please include a CV and cover letter with your email message. Position description: Reporting to the Associate Director, Regulatory Operations, the Senior Associate of Regulatory Operations will assist with the development and implementation of systems and procedures used to support regulatory submission activities including eCTD production, document publishing, and document manageme...
ARIAD Pharmaceuticals | Cambridge, MA, 02139 | 8
Summary Coordinates and prepares submissions to regulatory authorities worldwide. Compiles all materials required for submissions. Reviews and approves clinical trial submissions prepared by external sources. Keeps abreast of regulatory procedures and practices. Develops and documents department best practices. Duties and Responsibilities · Liaise proactively with other functions and participate as departmental member of cross functional teams, representing department position and ensuring teams accomplish requirements on time. · Lead and coordinate the preparation (including authoring when...
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