Job Description

Regulatory Affairs/Quality Assurance Manager, based in Netherlands

Servier Netherlands is looking for a colleague to join their team as Regulatory Affairs/Quality Assurance Manager at our office in Leiden. This position offers an opportunity to work within the RA/QA team, with broad responsibilities and a focus on our Netherlands-Nordics cluster.

Scope of the role

In the Netherlands-Nordics cluster (NeNo), Servier has a particular focus and expertise in the fields of oncology and cardiometabolism & venous disease. In this role you will be part of a small team of motivated experts where your main responsibility will be Regulatory Affairs and Quality Assurance for the Netherlands. You will manage/coordinate Regulatory Affairs activities for the Netherlands and support the NeNo cluster as well as our headquarters with your expertise in this area. You will also be managing tasks and providing expertise in the area of Quality Assurance with the main focus on the Netherlands. In addition, you will have the opportunity to work with the Nordic countries for Regulatory Affairs as well as Quality Assurance.

There may be a possibility to take on the “Responsible Person GDP” responsibility in The Netherlands.

You will report to the NeNo RA/QA Lead and work in close collaboration within the small NeNo Regulatory Affairs/Quality Assurance Team in which the roles will support and act as back up for each other.

For the Regulatory Affairs part

You will be Local Regulatory Affairs (LRA) for the Netherlands and Deputy for the Nordics. Your tasks will consist of, but not be limited to, the following:

• Local registration strategy.
• Local activities related to the maintenance of existing MAs, new MAs and launch as well as withdrawals. This includes the preparation and review of documentation, translations, management of artwork and updating of databases.
• Ensuring compliance with all applicable regulatory requirements, policies and laws in the Netherlands and the Nordics.
• Regulatory Intelligence.
• Managing Risk Minimization Measures and Dear Healthcare Provider Communications at local level.

For the Quality Assurance part

You will be the Responsible or Deputy for all Quality Assurance activities in NeNo. Your tasks will consist of, but not be limited to, the following:

• Have an overview, as deputy, of all GxP activities in The Netherlands.
• Involved in the maintenance of the Quality Management System (QMS), including writing/updating SOPs.
• Management of shortage notifications and exemptions.
• As back up, quality complaints management, reconciliation and reporting.
• As back up, management of potential recalls and falsified medicines.
• Back up for batch release for the Netherlands at the warehouse.
• Updating databases and overviews e.g. partner agreements and quality documents.
• Coordination of deviations, CAPA and Change Control processes.
• Coordinating in the case of audits and GDP inspections.
• Staying up to date with EU and local requirements related to Quality and GDP.

There may be a possibility to take on the “Responsible Person GDP” responsibility in The Netherlands, ensuring that the company complies with the principles and guidelines related to GDP.

In this position you will collaborate internally within the NeNo RA/QA Team, with the global functions as well as with colleagues within the NeNo cluster, and also externally with service providers as well as have contacts with the local health authorities in the Netherlands as well as the Nordics.

Candidate Profile

The qualifications we believe will help you thrive and be successful in this position are the following:

• University degree in Life Sciences.
• Solid experience in EU Regulatory Affairs.
• Experience in Quality Assurance, or a willingness to learn and expand your areas of expertise to Quality Assurance.
• Broad experience and knowledge of Regulatory legislation and procedures within EU as well as in The Netherlands.
• Experience and knowledge of GDP within EU and The Netherlands, or a willingness to learn.
• Dutch native language and high proficiency in spoken and written English.

We are looking for someone who has an interest in as well as the ability to familiarize yourself with new areas of expertise. As a person, you demonstrate a flexible way of working, you want to take on responsibility and you get things done. You communicate and work well with others. You enjoy supporting others and sharing your expertise within the team. Additionally, you are structured and thorough with a good attention to details.