The NA GBU Lead-Sanofi-Genzyme will report to the Vice President (Head), Global Regulatory Affairs, North America and will be responsible for leading a portfolio of development and marketed products in the rare disease, MS, and I&I areas. In this capacity, the NA GBU Lead will also lead a group of US regulatory experts, and be responsible for the overall US strategy for products in the portfolio.
The Sanofi-Genzyme portfolio is large and diverse and is comprised of some of the highest priority projects within the Sanofi business. The US based regulatory team provides support to both development and marketed products. Given the importance of the GBU to the Sanofi business, the NA Lead should be an expert in regulatory drug development and have expertise in at least some of the therapy areas covered by the GBU. The Lead will need to be able to manage a large portfolio while also providing coaching and mentoring to more junior staff. The NA Sanofi-Genzyme GBU Lead must build solid relationships with the appropriate FDA Review Divisions responsible for the Sanofi-Genzyme portfolio of products.
Specific requirements and responsibilities include:
Management of the Sanofi-Genzyme development and marketed product portfolio.
Develop and maintain a good working relationship with internal and external stakeholders, including the FDA.
Lead efforts in launching new products in the US and maintain the marketed products in the portfolio. In addition to development activities, the NA GBU Lead will also need to drive regulatory strategy for life cycle management activities for products in the portfolio.
Work with the Sanofi-Genzyme labeling strategy leads within the team to ensure labeling discussions occur as early in development as possible.
Working with the Global GBU Head and the appropriate GPTs/GRTs, represent the US regulatory position to senior management as needed (TPSC. DWG, IDC etc…), ensure peer review of key regulatory documents and submissions to maintain consistent quality across programs in the portfolio.
Serve as the line manager for a staff of approximately 5. Serve as a coach and mentor to staff and establish objectives and development goals for the US based team.
Develop and maintain a close working relationship with the global Sanofi-Genzyme GBU regulatory Head, and team, and ensure coordination of US regulatory strategies with the global teams (Blueprint model).
Ensure compliance with all internal and external requirements and procedures, including internal SOPs/QDs and FDA regulations.
Foster an environment/culture of learning and sharing of best practice within the Sanofi-Genzyme team and across all GRA units.
10-15 years industry experience, with at least 10 years working in Regulatory Affairs (regionally or globally). Significant experience in other relevant functions will be considered.
Proven track record of development success in developing and getting products to the market (NDA/BLA/MAA/JNDA submissions and approvals)
A BS in a scientific discipline. An advanced degree is preferred.