Head, Global Regulatory Oncology
Bridgewater, New Jersey, Cambridge, Massachusetts
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The Head, Global Regulatory Oncology will report to the GRA-Head, Specialty Care and lead a group of Global Regulatory Team Leaders (GRTLs) in Oncology and will be accountable for the global regulatory strategy for products in the portfolio.
Some specific elements of the role include:
- Ensure management of the oncology development product portfolio and help to define both current development and life cycle management projects in that area
- Lead the development and execution of long-term global regulatory strategy for the product portfolio
- Provide relevant input to oncology products’ Global Regulatory Product Strategy (GRPS) and ensure preparation of the oncology 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 oncology 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 agency discussions for projects as needed
- Ensure that management is aware of any major issues with projects, including any changes to risks, so that the appropriate message is communicated with a single regulatory voice to any key project governance milestone committee(s)
- Align the regulatory affairs function in line management while ensuring senior executives have strong connections with the P&L business unit
- Work with the oncology labeling strategy leads to ensure labeling discussions occur as early in development as possible
- Lead the global regulatory oncology GRTL team and provide coaching and mentoring; foster an environment and culture of learning and sharing of best practices within the oncology team, and across other TA GRA units
- Work in close collaboration with the other TA heads (Rare Disease, MS, Immunology)
- Represent GRA as a member of the Therapeutic Area Review Committee (TARC), a group led by the Oncology Development Head and Commercial Head, and be accountable for providing regulatory input for the projects globally
- May participate in any relevant Oncology Business Unit New Product Planning (NPP) review when called upon 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 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
- Bachelor's degree in scientific field required. Ph.D., Pharm.D 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 Oncology.
- 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.
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.
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