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Regulatory Affairs Specialist V Regulatory Affairs Specialist V
Ref No.: 18-16130
Location: Cambridge, Massachusetts
Manager is open to someone based in Bridgewater or Cambridge.
Senior Manager North America Sanofi Genzyme GRA (Global Regulatory Affairs)
The position will be based at the Cambridge, MA site as part of the Sanofi North America Regulatory Affairs Organization within GRA and will be responsible for being US regulatory lead on early development programs and providing US regulatory support for both development and marketed products in the Sanofi-Genzyme GBU. In this capacity, the Senior Manager North America Sanofi Genzyme GRA will be responsible for supporting development programs and marketed products working with the Global Regulatory team and (regions, Regulatory CMC, Regulatory Operations, EU authorized representatives, labeling).
Responsibilities:
Support the preparation of regulatory documentation and submission activities to meet business and agency milestones.
Lead the development and submission of initial INDs.
Create submission plans and manage timelines in MS Project, and document workflow from draft through finalization for US submissions.
Prepares routine submissions in compliance with department and regulatory requirements and guidelines. Assists with larger or more complex submissions.
Identify risks to timeline and assists the North American (NA) Regulatory lead
Work with Regulatory Operations to identify resource requirements and strategies to address overlapping resource demands and rate limiting factors
Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed
Ensure regulatory plans are monitored, progress/variance communicated on assigned programs
Collaborate within regulatory and cross-functional colleagues on the preparation and submission of regulatory filings, including major marketing applications in the US.
Prepare and review sections of regulatory submissions for IND/CTA original submissions and amendments, orphan designations, and pediatric investigation plans
Participate in regulatory research activities, as needed.

Minimum 4-6 years of regulatory experience in a biotech/pharma company
Excellent project management and writing skills, as well as a good understanding of the underlying science
Experience with preparation of initial INDs, DSURs and meeting briefing documents. Experience with BLA, NDA, or MAA a plus.
Understanding of the development of drugs and/or innovative biologics products. Experience in orphan drugs a plus
a working understanding of regulations and guidelines related to drug development and registration is required.
Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
Independently motivated, detail oriented and good problem solving ability
Demonstrated ability to handle multiple projects is required.
Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
Excellent communication skills and ability to influence across multiple functions