The role is primarily responsible for providing US regulatory strategic and tactical support for both development and marketed products in the immunology. In this capacity, the Manager/Senior Manager North America GRA will be responsible for providing US regulatory advice for development programs and marketed products working either independently as the North America Regional Lead (NARL) or supporting the North American (NA) Regulatory Lead. Further, the role will represent the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable to develop and maintain US aspects of regulatory strategy documents.
Support the preparation of regulatory documentation and submission activities to meet business and agency milestones.
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 to Management and any risks are highlighted.
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.
BS in pharmaceutical related scientific field.
Minimum 2-5 years of regulatory experience in a biotech/pharma company
Knowledge and Skills:
Excellent project management and writing skills, as well as a good understanding of the underlying science
Experience with preparation of initial INDs, CTAs, amendments, 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
Basic 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
Internal Number: R2516454
Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.