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

Role / Responsibilities:

Within the Corporate Regulatory Affairs, and belonging to the Diabetes & Cardiovascular Regulatory Global Business Unit, the Global Diabetes Therapy Area (“TA”) Head will be responsible for leading a broad portfolio of development and marketed products in the Diabetes therapy area. In this capacity, the Global Diabetes TA Head will also lead a group of Global Regulatory Team Leaders (“GRTLs”) in Diabetes, and be accountable for the global regulatory strategy for products in the portfolio. Given the importance of the Diabetes unit to the Sanofi business, the incumbent should be an expert in the Diabetes field and be able to manage a large portfolio while also providing coaching and mentoring to more junior staff. This individual must build a solid relationship with the Global Cardiovascular and Diabetes Business Unit. Global Regulatory Diabetes TA Head will report to the Head of Global Diabetes and Cardiovascular Regulatory Affairs and will have high visibility with top executives, including the Executive Vice President, Diabetes & Cardiovascular Global Business Unit and the Executive Committee.

Key responsibilities will include, but not necessarily be limited to, the following:

Projects Support

  • Ensure management of the Diabetes development product portfolio and help to define both current development and life cycle management projects in that area.

  • Lead the development and execution of the long-term global regulatory strategy for the product portfolio.

  • Provide relevant input to Diabetes products global regulatory product strategy (“GRPS”) and ensure preparation of the global Diabetes Global Regulatory Team Leaders (“GRTLs”) for the Transversal Product Strategic Committee reviews (“TPSC”) preparations.

  • Ensure peer review of key regulatory documents and submissions to maintain consistent quality across programs in the portfolio on a worldwide basis.

  • Develop and maintain a close working relationship with all the regional Diabetes TA regulatory leaders; leverage their skills and capabilities and ensure coordination and alignment of regional regulatory strategies and execution with the global regulatory project teams, including Agencies discussion for project when needed.

  • Be accountable for ensuring that management is aware of any major issues with projects, including any changes to risks, so that appropriate message is communicated on a single regulatory voice to any key project governance milestone committee.

  • Align regulatory affairs function in line management while ensuring senior people have strong connection with P&L business unit.

  • Work with the diabetes labeling strategy leads to ensure labeling discussions occur as early in development as possible.

  • Lead the global regulatory diabetes GRTLs team and provide coaching and mentoring; foster an environment/culture of learning and sharing of best practice within the Diabetes team and across all GRA units.

  • Work in close collaboration with the Global Regulatory Cardiovascular TA Head.

Business Support

  • Represent GRA as a member of the Therapeutic Area Review Committee (“TARC”) and be accountable for providing regulatory input for the project(s) globally.

  • May participate in any relevant Diabetes & Cardiovascular Global Business Unit New Product Planning (“NPP”) review when called by the Global Business Unit.

  • May be asked to participate in Due Diligence and, as needed, to provide regulatory input on potential new in-licensing opportunities.

  • May be asked to join portfolio review in order to provide relevant regulatory input to the business.

  • May be asked to represent GRA in Products Alert teams or Crisis teams related to the product portfolio.

  • Contribute to Regulatory priorities, budget, vision, quality and continuous improvement

Education / Experience:

  • Ph.D., PharmD or M.D. degree preferred.

  • 10-15 years of pharmaceutical/biotechnology industry experience, which shall include 10 years of Regulatory experience (regional or global) and worldwide experience of regulatory submissions and approvals.

  • Strong experience in the field of Diabetes.

  • Proven track record of development success in developing and getting products to the market (e.g., NDA/BLA/MAA/JNDA submissions and approvals).

  • Track record of post-marketing activities experience.

  • Experience in other relevant functions will be considered.

  • Bilingual written and speaking English.

  • Ability to lead projects in a matrix environment.

  • Negotiation skills and strong project management capabilities.

  • Capabilities to lead team and provide support to the GRTLs as needed.

  • Capabilities to manage transversal teams and relationships.

  • Change agent capable of leveraging strong teams across functions and providing real impact.

  • Various knowledge of R&D development and enabling functions.

  • Strong business acumen and analytical sense.

  • Ability to network internally and externally with regional stakeholders, clients, corporate management, public authorities.

  • Capabilities to work in an international/multicultural environment.

  • Rigorous and detail-oriented.

  • Excellent organizational skills.

  • Strong capacity of anticipation and management of unplanned events.

  • Strong skills in adaptation, reactivity and pro-activity, and communication.

#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.