Director, Global Regulatory Affairs - Oncology
Millipore Corporation

Job Info

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Location:The Director, Global Regulatory Affairs - Oncology is located on site at the Billerica, MA facility with domestic and international travel required. The Director, Global Regulatory Affairs - Oncology is responsible for the global regulatory strategy and execution for assigned projects in the oncology pipeline. Key AccountabilitiesRepresent Regulatory Affairs in Global Project Team(s) for your assigned project(s)Lead the global regulatory sub-team (GRST) for your assigned project(s). Ensure alignment of all GRST functionsDrive the regulatory submission process for all types of submissions through to approval. This includes the management and coordination of the preparation of all regulatory documentation, and ensuring all submission deliverables are of high quality.Partner with Regulatory Project Management and Submission ManagementEnsure optimal management of major regulatory agency interactions for your assigned projects including preparation of briefing materials, co-ordination of rehearsals and minutes. This may be done by an experienced Regional Regulatory Lead with strong support from the GRL.Develop optimal regulatory strategies that are aligned with the development plan for assigned projects.Matrix leadership role of GRST - ensure project resource requirements are suitably managed.Participate in cross-functional and GRA initiatives.

Who you are:

Minimum RequirementsAdvanced degree and at 6 +years of relevant experience3+ years of recent oncology development experienceExperienced strategist with a record of successful HA (Health Authority), interactions with FDA (Federal Drug Administration) and/or EMA (European Medicines Agency)Up to 15% domestic and international travel Preferred RequirementsDemonstrated strong matrix leader.Excellent spoken and written English.

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