International Regulatory Strategist

About the role

As an International Regulatory Strategist within Sanofi's Global Regulatory Team, you will provide regulatory expertise and deep international market knowledge to shape early opportunities and risks across multiple regions. You will work closely with local affiliates to ensure seamless integration of regulatory strategies into the global pipeline.

Key responsibilities

• Drive early engagement with international markets, sharing knowledge on clinical development programs and launch readiness.
• Build robust, scenario‑based regulatory strategies tailored to regional requirements while standardising dossier preparation.
• Partner with commercial teams to develop ready‑to‑deploy strategies for approved business cases.
• Act as the first line of response to health authority queries, drafting responses with subject‑matter experts.
• Maintain a deep understanding of evolving international regulatory landscapes and translate updates into actionable insights.
• Serve as regional regulatory lead, coordinating pre‑submission meetings and health authority interactions.
• Lead the definition and execution of international regulatory strategy as a key member of the Global Regulatory Team.
• Contribute to a harmonised “One Sanofi” regulatory voice through committee participation.

Required profile

• Proven experience in regulatory affairs within the pharmaceutical or biopharma sector.
• Strong knowledge of international regulatory environments across regions such as LATAM, MENA, EMEA, and APAC.
• Ability to lead cross‑functional teams and communicate complex regulatory concepts clearly.

Required skills

What we offer

• Opportunity to influence global regulatory strategy for a leading biopharma company.
• Collaborative environment with access to cutting‑edge scientific and AI‑driven resources.
• Competitive benefits and career development pathways.