Regulatory Affairs Officer - VIE Contract

Regulatory Affairs Officer - VIE Contract

• Location: Netherlands, Amsterdam
• Target start date: 01/10/2025

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.  

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.  

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.   

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Global Regulatory team as Regulatory Affairs Officer VIE and you’ll leverage your knowledge of regulatory affairs to contribute to the execution of the US, EU and/or global regulatory strategy for assigned projects, including Health Authority engagement.

You will also provide regulatory guidance on procedural and documentation requirements to Global Regulatory Team (GRT) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

• Management and conduct of the global regulatory activities for assigned projects in line with regulatory requirements. Provide operational support as needed on development and marketed products. Preparing, compiling, reviewing and processing the regulatory submissions for both pre-approval and registration maintenance activities such as IND, CTA, scientific advice, paediatric investigation plans, NDA/BLA/MAA, amendments/supplements and variations, response documents, annual reports, study protocols, study reports, investigator brochures, safety reports, etc.
• Coordinating and consulting with other concerned functions and the RS and GRL on the content, and assembly of regulatory documentation and ensuring consistency, completeness, and adherence to standards for all the regulatory submissions.
• Attending and participating in the assigned project/regulatory product development and submission teams, providing clear and consistent regulatory recommendations.
• Assist with regulatory communications with the Health Authorities for assigned products and activities, including preparing for Health Authority meeting requests, briefing books, meeting rehearsals/slides, meeting minutes of the Health Authority meetings and the generation of responses to the Health Authority queries.
• Support the Global Regulatory Team (GRT) in engagement with external organizations.
• Support the compilation, development, submission, and maintenance of worldwide regulatory filings.
• Track regulatory project status and informational documents.
• Coordinate required documentation with partners (e.g. CMC Team) or functional groups. Support operational and compliance activities for assigned deliverables. Develop, generate, execute and maintain submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant.
• Interfacing with global Regulatory partners and internal cross functional teams.
• Attending relevant functional area and project team meetings as required.

About you

Experience:

• Industry experience with regulatory affairs is highly preferred, for instance: experience in regulatory operations and coordination of regulatory documents, experience with the preparation of regulatory submissions.

Education:

• Physician, Pharmacist, Veterinarian or Life Sciences Master’s Degree preferred.

Technical and soft skills:

• Understanding of the pharmaceutical industry, drug development environment, and company processes and objectives, and knowledge of local and global pharmaceutical and health-related regulations and requirements (i.e. ICH, FDA, EU, etc.).
• Coordination skills including planning, organizing and ability to manage and organize the workload with autonomy, as well as motivate and lead people with the aim to submit specific deliverables to external organizations.
• Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor, and to understand scientific subject matters as well as the evolving regulatory policy and guidance.
• Ability to evaluate the impact of the regulations on drug development and the regulatory maintenance of Marketing Authorizations.
• Ability to communicate effectively and efficiently with other functional departments internally and externally, and to be agile and to work with different products, different regulatory environments (development and lifecycle), on several projects and to adapt rapidly to several ways of working of RSs and GRLs.

Languages:

• Fluent in English.

Why choose us? 

iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.  

Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work. 

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