Regulatory Coordinator Specialist

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role:

In this role you will support Therapeutic Areas of GRA with HA submissions. Prepare, review, sign documents to support GRA globally. Request CPPs from EMA and GMP/MLs from manufacturing sites and CMO’s. You will provide guidance on M1 documents to support rollout and lifecycle management of products globally, be responsible for daily operations to ensure regulatory, compliance, tax and legal requirements met. You will also act as cover for Manager during absence, while reporting to Manager based in UK and into Global RA, Germany, while being a part of global team located throughout Europe, US and India. You will guide and support company's functions on the legal role and responsibilities, be the contact for NL vendors to ensure uninterrupted service and payment of all invoices. You will also align with internal functions and EMA on invoicing/payment queries, ensure invoices paid within timelines and as per EU legislation. The role involves interaction with HA and Agencies as necessary as representative of MAH, support continuous review of processes under team responsibility including rollout and training, upload documents and data to regulatory databases, ensuring quality and integrity.

Who You Are:

• Graduate degree/equivalent or with 3 years Regulatory experience.
• Fluent in English and Dutch.
• Highly motivated with ability to work with limited supervision.
• Excellent management and prioritising skills.
• A pragmatic approach to problem solving.
• An eye for detail to ensure consistent delivery of quality documents.
• Strong team player with excellent communication and interpersonal skills.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!