Regulatory Strategist

• Location: Amsterdam, the Netherlands

About the job

We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world.

As a key member of the GRT, and strategic partner to the GRL, the RS leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority interactions.

The Regulatory Strategist provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Main 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
• Contributes to the Global Regulatory Team (GRT) for assigned projects in alignment with the team’s one regulatory voice for providing strategic input on the TPP, business planning, governance and committees. May be requested to lead Global Regulatory Team meetings
• May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed; Leads the IND/ CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation
• Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations
• Leads submission team or regulatory subteam to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the core global dossier / collaborates with regional lead where region-specific submissions are applicable
• Accountable for developing the Health Authority engagement and interaction plans for their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading the team through meeting preparations and moderating the meeting itself for the projects in their remit.
• Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, 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

About you

• BS/BA degree in a relevant scientific discipline required.  Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred
• At least 6 years of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global), in early and late stage development of multiple modalities; experience within regulatory CMC not directly applicable
• Proactively contribute with curiosity and openness to diverse perspectives
• 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
• Effective communication skills, specifically strong oral and written presentation skills
• Lead 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
• Experience working in and strong knowledge of electronic document management systems (e.g. Veeva vault)
• Demonstrated ability to handle multiple projects/deliverables simultaneously
• Strong sensitivity for a multicultural/multinational environment

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

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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