Amsterdam, North Holland, Netherlands · On-site
$65k–$86k/yr
Location: Amsterdam, the Netherlands Job type: Full time, Permanent About the job: Join our dynamic team as a full-time Regulatory Affairs (RA) Manager in the Netherlands Dutch team! Under the guidance of our Head of Reg…
Skills: EU Regulations, Regulatory Strategy, Labeling Compliance, Risk Management, Health Authority Interaction
Cambridge, Massachusetts, United States · On-site
$236k–$341k/yr
Job title: Senior Medical Director, AATD Location: Cambridge, MA Travel: Up to 25% travel expected About the job Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological…
Skills: Medical Strategy, Scientific Leadership, KOL Engagement, Clinical Development, Medical Affairs
Hyderabad, Telangana, India · On-site
Job title: Real-World Evidence Data Scientist Grade: NAHiring Manager: Group Lead – RWE Analytics & Evidence Generation, SBOLocation: Hyderabad,% of travel expected: Travel required as per business need Job type: Permane…
Skills: Machine Learning, Artificial Intelligence, Deep Learning, Real-World Evidence, Statistical Modeling
Paris, Ile-de-France, France · Hybrid
$48k–$64k/yr
Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail. This job offer is accessible to all, regardless of gender.…
Skills: Data Pipeline Design, Data Modeling, ETL/ELT Processes, SQL, Snowflake
Vitry-sur-Seine, Ile-de-France, France · Hybrid
$64k–$85k/yr
Job Title: Senior Principal Scientist I, Translational Disease Biology Location : Vitry-sur-Seine – France About the job As Senior Principal Scientist I within the Biological Insights & Integration (BII) cluster in Targe…
Skills: Translational Disease Biology, Immunology & Inflammation, Oncology/IO, Target Identification, Precision Medicine
Cambridge, Massachusetts, United States · Hybrid
$101k–$145k/yr
Job title: Senior Scientist Cellular and Spatial Biology Location: Cambridge, MA About the Job We are looking for a highly motivated and innovative scientist to join the Target, Disease & Systems Biology (TDSB) departmen…
Skills: Bulk RNA-seq, Single-cell RNA-seq, Single-nucleus RNA-seq, Spatial Transcriptomics, Spatial Proteomics
Vitry-sur-Seine, Ile-de-France, France · On-site
$48k–$64k/yr
Job Title: Senior Scientist Biochemical Analysis Location: Vitry-Sur-Seine – France About the job As a Senior Scientist Biochemical Analysis within our BioProcess Analytics service in the BioAnalytics Department, you wil…
Skills: HPLC, UPLC, iCIEF, Capillary Electrophoresis, UV Spectrophotometry
Cambridge, Massachusetts, United States · On-site
$266k–$385k/yr
Job title: Global Brand Lead, Oncology Location: Cambridge, MA / Morristown, NJ About the job Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Spe…
Skills: Global Brand Strategy, Life Cycle Management, Oncology Expertise, Commercial Leadership, Strategic Thinking
Petaling Jaya, Selangor, Malaysia · On-site
Job title: People Services Generalist Location: KL About the Job: At its core, this role is about actively managing, triaging, and resolving tickets end-to-end through ServiceNow (OneSupport) — owning each case from the …
Skills: Case Management, ServiceNow, Workday HCM, HR Operations, Employee Lifecycle Management
Frankfurt, Hesse, Germany · On-site
$101k–$135k/yr
About the Role The Head of Order to Serve GSA MCO leads country-level Order to Serve (O2S) operations within Sanofi's Global Finance Services (GFS) / Business Operations organization. GFS provides end-to-end services glo…
Skills: Order to Cash, Sales Order Management, Claims & Disputes Management, SAP, Salesforce
Milan, Lombardy, Italy · Hybrid
Clinical Study Unit Intern Milan, Italy About the job Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while help…
Skills: Clinical Trial Management, Regulatory Authorizations, Digital Innovation, AI Solutions, Microsoft Office
Mumbai City, Maharashtra, India · On-site
Job title: Scientific Sales Executive Location: Siliguri About the job The Scientific Sales Executive is responsible for promoting pharmaceutical products to healthcare professionals (HCPs), building and maintaining rela…
Skills: Communication, Presentation Skills, Selling, Negotiation, Product Knowledge
Budapest, Central Hungary, Hungary · Hybrid
$10944k–$14592k/yr
Job title: Investigational Product Manager Location: Budapest, Hungary Job type: Permanent, full-time Hybrid working (60% office, 40% home) About the job Are you ready to shape the future of medicine? The race is on to s…
Skills: IMP Management, Clinical Trial Distribution, GxP Knowledge, Supply Chain Management, Vendor Oversight
Poriebhat, Goa, India · On-site
Job Title- Quality Business Owner - PQR Location- Goa About the Role Implement Quality management systems & Compliance at the Goa Pharma site, adhering to global quality documents and HSE guidelines with optimum utilizat…
Skills: Product Quality Review, Quality Management Systems, cGMP Compliance, Regulatory Audits, Change Control
Milan, Lombardy, Italy · Hybrid
Medical Affairs Intern Milan, Italy About the job Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping …
Skills: Scientific Content Creation, Medical Plan Management, Literature Alerts, Scientific Documentation, Internal Staff Training
Gentilly, Ile-de-France, France · On-site
Job title: apprenticeship 12/24 months - internal control Location: GentillyUntil : September 2026 About the job As an internal control apprentice within our Internal Control R&D Medical LTE, you will contribute to stren…
Skills: Internal Control, Risk Management, Data Analysis, Business Intelligence, Data Visualization
Singapore, Singapore · On-site
Position: Quality Control Support Hiring Manager: Manager, QC Raw Material & Lab Service Location: Tuas, Singapore About the job: We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless p…
Skills: Quality Control, QMS, GMP, Method Validation, Equipment Qualification
Budapest, Central Hungary, Hungary · Hybrid
$7603k–$10138k/yr
Location: Budapest, Hungary Grade: L1-2 About the job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a c…
Skills: SAP R3/S4, SAP SD Module, Microsoft Excel, Master Data Management, Order to Cash
Marcy-l'Étoile, Auvergne-Rhône-Alpes, France · Hybrid
Intitulé du poste : alternance 12 mois - amélioration continue et gestion projets Lieu : Marcy-L’EtoileA partir de : septembre 2026 À propos du poste En tant qu’alternant.e amélioration continue et gestion projets au sei…
Skills: Continuous Improvement, Project Management, CAPA, Anomaly Management, Lean Management
Hyderabad, Telangana, India · On-site
Job title: Team Lead - Trade & Revenue Management Location: Hyderabad % of travel expected: Travel required as per business need, if any Job type: Permanent and Full time About the job Strategic context: As part of GTMC,…
Skills: Commercial Analytics, Revenue Management, Gross-to-Net Analytics, Tender Management, Data Governance
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Manage regulatory affairs initiatives for product portfolios in the Netherlands and Belgium, acting as the bridge between national health authorities and corporate headquarters. Ensure labeling compliance, manage risk management plans, and review promotional materials for legal adherence.
Requires a Master's degree in medical, pharmaceutical, or biomedical sciences with comprehensive knowledge of EU regulations. Candidates must be native Dutch speakers and fluent in English with strong networking and analytical skills.
Location: Amsterdam, the Netherlands
Job type: Full time, Permanent
About the job:
Join our dynamic team as a full-time Regulatory Affairs (RA) Manager in the Netherlands Dutch team!
Under the guidance of our Head of Regulatory Affairs NL, you'll take charge of steering Regulatory Affairs initiatives for our portfolio in the Netherlands and Belgium. As our RA Manager, you'll serve as the local bridge between National Health Authorities, our corporate headquarters, and various internal stakeholders, ensuring seamless collaboration on a wide array of Regulatory matters. Plus, you'll play an essential role in the promotional review process, putting your expertise to work in shaping the future of our brand. You will have the responsibility for your own product portfolio, but with the support you need from the local regulatory team and your RA colleagues in the North European affiliates.
But that's not all! You'll have the opportunity to dive into exciting projects within the NE cluster and across the EU region.
Joining our strong, experienced team means you'll be surrounded by support, fueling your personal and professional growth every step of the way. After all, your success is our success.
Ready to embark on this thrilling journey? Take the first step and apply today!
Responsible for cross-country Regulatory Affairs activities for BE and NL for the designated portfolio (NP, MRP/DCP, CP) in Rare Diseases, Rare Blood Disorders and/or General Medicine Franchises
Responsible for optimal process control (content and procedure)
Responsible for obtaining registration
Responsible for maintaining registrations, as part of the product lifecycle management
Responsible for keeping track of changes in relevant national and European legislation and regulations and ensuring optimal follow-up/response to these changes within Sanofi, as well as ensuring knowledge sharing and storage within the organization
Contribution to registration strategy by providing advice and strategic input to various stakeholders (including local and Global stakeholders)
Performing activities required to Sanofi products (such as Named Patient Programs)
Responsible for labelling compliance of all Sanofi products, in accordance with Sanofi procedures and based on current laws and regulations
Update of product information
Responsible for the availability of the most up-to-date packaging and package insert on the market
Responsible for the coordination of updates
Co-ordinate the local health authority approval and implementation of risk management plans and DHPCs and educational material
Ensure availability of current approved product information for risk minimization (SmPC, educational material, PIL, compendia)
Responsible for industrial compliance of all Sanofi products, in accordance with Sanofi procedures and based on current laws and regulations
Responsible for restricting artwork destruction cost
Responsible for optimal process control (content and procedure) of all projects and managing Regulatory Affairs Officers
Responsible for accurate and timely reporting in the dedicated systems
Support the drawing up, monitoring and executing plans for registration and notification processes. Providing insight into the results and activities of Regulatory Affairs by means of periodic and ad hoc reports and/or analyses
Ensure problem identification and prioritization
Act as the interface between the company and local regulatory authorities.
Build good relationship, making Sanofi a recognized partner with the agencies
Lead MEB meetings together with GRA stakeholders
Provide RA input to product portfolio optimization and product pruning at affiliate level and give RA input to global product portfolio optimization strategies
Ensure review and approval of promotional and non-promotional materials to ensure that they are compliant with current law and legislations, code of conduct and internal guidelines
Master’s degree in medical, pharmaceutical, or biomedical sciences
Comprehensive knowledge and operational expertise of the EU regulations
Networking: Building relationships and networks that are useful in achieving objectives. Using informal networks effectively to get things done
Problem analysis: Identifying issues; recognizing important information; linking data. Tracing potential causes of problems; searching for appropriate data
Verbal communication: Make ideas and opinions clear to others using clear language, gestures and non-verbal communication. Customize language and terminology to others
Independence: Taking actions that are based more on one’s own convictions than on a desire to please another. Sets his/her own course
Stress resistance: Continue to perform effectively under time pressure, in the face of setbacks, disappointment or opposition
Planning and organizing: Effectively setting goals and priorities and identifying time, actions and resources needed to achieve certain goals
Openness to AI tools and digital innovation: Willingness to leverage AI-powered solutions and emerging technologies to enhance regulatory strategy, streamline submissions, and improve decision-making processes
Language: native Dutch speaker and fluent English
Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
The salary range for this position is :€65 000,00 - €86 333Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.
We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms
Offices: 46 Avenue de la Grande-Armée, Paris, France 75017, FR · Karachi, Sindh 75300, PK · 11 Beach Rd, Singapore, Singapore, SG · Francisco Garcia Cortinas 2357, Montevideo, 11300, UY · 1 Discovery Dr, Swiftwater, PA 18370, US
We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms
Offices: 46 Avenue de la Grande-Armée, Paris, France 75017, FR · Karachi, Sindh 75300, PK · 11 Beach Rd, Singapore, Singapore, SG · Francisco Garcia Cortinas 2357, Montevideo, 11300, UY · 1 Discovery Dr, Swiftwater, PA 18370, US
