Regulatory Strategist

Role Summary

Regulatory Strategist responsible for providing regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams across regions to ensure delivery of business objectives within Immunology and Inflammation. Develop regulatory product strategies and contribute to a harmonized regulatory voice.

Responsibilities

• Enables the GRL by providing quality regulatory input and position to internal business partners, including clinical development teams, commercial and Global Regulatory Team for assigned projects
• Liaises with clinical, commercial and other internal business partners in partnership with the GRL to enable successful regulatory outcomes
• Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate committees, forums at the direction of the GRL
• Proactively contribute with curiosity and openness to diverse perspectives
• Emerging understanding of clinical development of drugs and/or novel biologics products
• Understanding of business acumen, leadership, influencing and negotiation skills
• Contribute to operational and compliance activities for assigned deliverables, develop, execute and maintain including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant
• Effective communication skills, specifically strong oral and written presentation skills preferred
• Ability to work in electronic document management systems (e.g. Veeva vault, Plai) is a plus
• Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred
• Strong sensitivity for a multicultural/multinational environment

Qualifications

• BS/BA degree in a relevant scientific discipline, or MSc in Biology, Life Science, or related field with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience OR Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required

Soft Skills

• Understanding of clinical development of drugs and/or innovative biologics products
• Demonstrated experience with driving the preparation of regulatory documents (e.g. (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents) and negotiating with a national/regional Health Authority
• Emerging business acumen, leadership, influencing and negotiation skills
• Ability to use appropriate interpersonal styles and techniques to build internal and external networks and lead discussions with internal and external stakeholders
• Effective communication skills, specifically strong oral and written presentation skills
• Experience working in and strong knowledge of electronic document management systems (e.g. Veeva Vault RIM, Plai)
• Demonstrated ability to manage multiple projects/deliverables simultaneously
• Strong sensitivity for a multicultural/multinational environment

Education

• BS/BA degree in a relevant scientific discipline, or MSc in Biology, Life Science, or related field with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience OR Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required