Regulatory Strategist - Vaccines Job at Sanofi, Morristown, NJ

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  • Sanofi
  • Morristown, NJ

Job Description

The Regulatory Strategist – Vaccines role involves developing and executing regulatory strategies for vaccines in post marketing and life cycle development stages to support the Vaccines Global Business Unit. Reporting to the PPH Global Regulatory Lead, the position focuses mainly on combination pediatric vaccines but may support other therapeutic areas. Responsibilities include providing regulatory input to internal teams, liaising with clinical, medical, commercial, and supply functions, contributing to a harmonized regulatory voice, serving as a point of contact with Health Authorities, identifying regulatory risks, contributing to global regulatory project strategy, leading submission teams, supporting operational and compliance activities, and developing regulatory submission planning. The role requires knowledge of clinical development, biological products, vaccines, and regulatory affairs with experience in US, EU, and international regulatory environments. A BS/BA degree in a relevant scientific discipline is required, with advanced degrees preferred, and at least 6 years of pharmaceutical/biotechnology experience including 3 years in regulatory affairs. Strong communication, leadership, and project management skills are essential.

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Job Tags

Full time,

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