Regulatory Coordinator Specialist

Regulatory Coordinator Specialist

Work Your Magic with us! Start your next chapter and join EMD Electronics.

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.

Everything we do in EMD Electronics is to help us deliver on our purpose of being the company behind the companies, advancing digital living. We are dedicated to being the trusted supplier of high-tech materials, services, and specialty chemicals for the electronics, automotive, and cosmetics industries. We foster a global collaborative organization made up of individuals who have the passion to win, obsess about the customer, are relentlessly curious, and act with urgency. Together, we push the boundaries of science to make more possible for our customers.

Your Role:

In this role, you will support Therapeutic Areas of GRA with HA submissions. Prepare, review, and 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 are 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 a 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 are 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 prioritizing 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! 😊

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

“We are dedicated to being the trusted supplier of high-tech materials, services, and specialty chemicals for the electronics, automotive, and cosmetics industries.” John Doe, Senior Manager