Associate Director Regulatory Affairs Oncology
Millipore Corporation

Job Info

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Location:The Associate Director Regulatory Affairs - Oncology is located on site at the Billerica, MA facility with domestic and international travel required. The Associate Director Regulatory Affairs - Oncology is responsible for the regulatory strategy development and execution for their assigned projects in the United States, and supporting other North American countries. Key Accountabilities:Represent and provide input for your respective region to the GRST (global regulatory sub-team). May provide direct input to the GPT in case of major region, particularly where the GRL is not in that region.Lead the respective regional regulatory sub-team.Drive the regulatory submission in your respective region.Ensure optimal planning in alignment with cross-functional team, and execution to plan for both development submissions and maintenance submissions to ensure ongoing compliance. Partner with Regulatory Project Management and Submission ManagementFunction as direct contact to a local Health Authority i.e., Federal Drug Administration and lead the direct interactions with the respective local HA in this case.Contribute to the global regulatory strategy with local / regional strategy for assigned projects.Matrix leadership role of respective Regional Regulatory STParticipate in cross-functional and GRA initiatives.

Who you are:

Minimum Requirements:Advanced degree and 3+ years' experience in drug development, preferably in regulatory affairsUp to 15% domestic and international travel Preferred RequirementsDemonstrated matrix leadership skill.Excellent spoken and written English.

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