Regulatory Affairs Manager

• 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 Layla Fitoury, 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!

Main responsibilities:

Obtain and maintain registration in The Netherlands and Belgium

• 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

Regulatory strategy and law/legislation

• 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)

Labeling compliance

• 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

Risk Management

• 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)

Industrial compliance

• 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

Planning and reporting

• 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

Health Authority Interactions

• 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

Portfolio Optimization

• Provide RA input to product portfolio optimization and product pruning at affiliate level and give RA input to global product portfolio optimization strategies

Promotional materials

• 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

About you:

• 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