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| Associate Director MA Open (J#27380) Title: Associate Director Company: Alnylam Pharmaceuticals Associate Director/Director, Regulatory Affairs ID: 62279 Company Name: Approximate Salary: Not Specified Location: Cambridge, Massachusetts Country: United States Industry: Other Position type: Full Time Experience level: Education level: Short Description Regulatory Long Description Reporting to the Vice President of Regulatory, the Associate Director/Director of Regulatory Affairs will work with a cross-functional team to implement regulatory strategy, data and submission packages to US and international regulatory agencies. Responsibilities include actively contributing to the development and implementation of regulatory strategy for specific projects including identifying and assessing regulatory risks, serving as the regulatory representative on project teams, active involvement in the writing and review of regulatory submissions and interfacing with authorities, coordinating all aspects of regulatory submissions and proactively keeping updated on regulatory requirements worldwide.Qualifications Minimum 8 years pharmaceutical/biotechnology industry experience, 5 plus years regulatory experience working on biotech programs. More... | |||
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