This position will be based in Bridgewater as part of the Sanofi North America Regulatory Affairs Organization within GRA and will be responsible for providing US regulatory support for both development and marketed products in the Sanofi-Genzyme GBU. In this capacity, the AD/Director, NA Regulatory Affairs will be responsible for development programs and marketed products working with the Global Regulatory team and Global Regulatory Lead (regions, Regulatory CMC, Regulatory Operations, EU authorized representatives, labeling). Specific responsibilities include:
Represent NA GRA as a member of cross functional regulatory project team and provide regulatory input globally.
Act as a single point of regulatory contact for the team on regulatory issues as directed by the GRL.
Work with and participate on multi-disciplinary matrixed project teams that work to project deadlines while adhering to regulatory requirements for programs and products.
Ensure development of robust regulatory strategies for new development programs and be accountable for development and maintaining regulatory strategy documents.
Primary liaison with FDA and other HAs for products in remit.
Ensure appropriate communication of Health Authority documents and appropriate updating and compliance of applications (PSURs, DSURs etc…).
Consults with senior management to develop and communicate regulatory strategies and opinions for products and programs.
Participate in the development, monitoring and updating of standards and processes related to drug and biologics regulations.
Provide global support for regulatory issues or related questions that may arise related to products in the portfolio.
Supervise, and/or coach mentor, junior staff supporting regulatory team.
Ensure compliance with all regulatory and internal Sanofi policies
At least 5 years regulatory drug development experience
Prior experience working on and submitted, INDs, CTAs, BLA, NDAs, MAAs and working in a global environment.
A BS in a scientific discipline. An advanced degree preferred.