Sanofi Group NA GBU Lead Sanofi-Genzyme (Senior Director/AVP) in Waltham, Massachusetts

Job Description

NA GBU Lead Sanofi-Genzyme (Senior Director/AVP) - Global Regulatory Affairs (GRA)

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.

Minimum Requirements

  • 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.

#LI-SA

Sanofi US Services, 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.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.