R&D
Wo deine Neugier die Wunder der Wissenschaft antreibt

Location: Amsterdam, Netherlands

Job type: Permanent, Full Time | Hybrid Work Policy | Travel: max 5%

About the job:

As Regulatory Strategist within the Global Regulatory Affairs department, you'll leverage your regulatory expertise to contribute to the definition and execution of global regulatory strategies for Sanofi’s products, enabling successful regulatory outcomes through strategic partnerships and Health Authority interactions. This role will be in the Rare Diseases and Rare Blood Disorders therapeutic area. Ready to get started?

You'll join our department as a key strategic partner to the Global Regulatory Lead (GRL), working on developing and executing regulatory product strategies in both the development stage and post-marketing phase. This role offers the opportunity to work on activities across regions (US, EU, and global), providing regulatory expertise and guidance to cross-functional teams to ensure the delivery of business objectives in the Rare Diseases and Rare Blood Disorders therapeutic area.

About Sanofi:

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system– and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main responsibilities:

• Contribute to the definition of global regulatory strategy and drive the execution of aligned US, EU, and/or global regulatory strategies for assigned projects, including Health Authority interactions

• Enable the Global Regulatory Lead (GRL) by providing quality regulatory input and strategic positioning to internal business partners, including clinical development teams, commercial teams, and the Global Regulatory Team

• Provide regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams, working flexibly within and across regions

• Liaise with clinical, commercial, and other internal business partners in partnership with the GRL to enable successful regulatory outcomes

• Contribute to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate committees and forums at the direction of the GRL

• Serve as regional/local regulatory lead and point of contact with Health Authorities for projects/products in your remit, as needed, and may lead Health Authority meetings and preparations as designated

• Lead the IND/CTA submission strategy to ensure preparation timelines meet project timelines for clinical trial initiation

About you:

• Experience: Proven track record in pharmaceutical/biotechnology industry (min. 6 years) with relevant Regulatory Affairs experience (min. 4 years; EU or US and/or global), preferably in the development phase; experience with products in the Rare Diseases area or biologics is a plus

• Soft skills: Proactive contributor with curiosity and openness to diverse perspectives; strong business acumen with leadership, influencing, and negotiation skills; effective communication with strong oral and written presentation abilities; ability to handle multiple projects/deliverables simultaneously; strong sensitivity for multicultural/multinational environments

• Technical skills: Emerging understanding of clinical development of drugs and/or novel biologics products. Adaptability to evolving digital regulatory landscapes, such as artificial intelligence (AI) and generative AI (GenAI) enabled applications, and commitment to maintaining compliance with traditional GxP requirements. Ability to work in electronic document management systems (e.g., Veeva Vault) is a must. Experience with regulatory intelligence systems and digital submission platforms is highly valued.

• Education: BS/BA degree in a relevant scientific discipline, or PharmD, MSc in Biology, Life Science, or related field

• Languages: Fluent in English (spoken and written)

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team

• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave

• Work in a hybrid environment with flexibility and minimal travel (max 5%), supporting work-life balance

• Make a meaningful impact on patients with rare diseases and rare blood disorders through strategic regulatory work

#LI-EUR

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Pursue Progress. Discovery Extraordinary.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.