Regulatory Strategist

Role Summary

Regulatory Strategist responsible for providing regulatory expertise and guidance on procedural and documentation requirements to cross-functional teams, leading regulatory efforts in the development stage of drug products within Immunology and Inflammation.

Responsibilities

• Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the 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