Sanofi Group Senior Manager, Regulatory Affairs in Cambridge, Massachusetts
The position will be 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).
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.
Knowledge and Skills:
BS in pharmaceutical related scientific field.
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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.