Offer Responsible for the global registration and lifecycle management of a diverse pharmaceutical portfolio; Direct interaction and collaboration with health authorities worldwide; A role where you contribute to new R&D projects and innovative developments of existing products; The possibility to grow into a leadership position.
Job description As a Senior Regulatory Affairs (RA) Manager, you will be responsible for managing and coordinating registration dossiers for a part of Eurocept's pharmaceutical portfolio.
This global portfolio includes products registered in various regions, such as Europe, America, Australia, the Middle East, and South Africa.
You will prepare all necessary documents for new registrations and submit them.
You ensure timely and accurate coordination with internal departments for content input and prepare for Scientific Advice and pre-submission meetings.
You will take care of drafting and maintaining the CMC documentation.
You will also play a central role in the lifecycle management of pharmaceuticals, where you are responsible for post-approval variations and have a clear understanding of all regulatory aspects related to manufacturing processes, formulations, packaging, and artwork.
Collaboration is crucial in this role; you will work together with colleagues from the Quality, Production, and Pharmacovigilance departments to ensure the regulatory strategy is accurately implemented.
You will actively participate in cross-functional project meetings and be responsible for the accuracy of printed materials such as SmPCs, leaflets, packaging, and labels.
In this position, you will report to the Global Associate Director of Regulatory Affairs and will be involved in projects that go beyond individual products.
Your ability to communicate effectively, coordinate, and your pragmatic approach makes you the ideal candidate to successfully fulfill this dynamic and responsible role.
Profile A completed master's degree in pharmaceutical sciences, pharmacy, chemistry, biology, biochemistry, or a related discipline; Several years of experience in Regulatory Affairs with knowledge of European procedures and regulatory legislation; Experience with the drug development process and CMC documentation is a plus; Strong analytical and pragmatic thinking skills with a focus on problem-solving; Ambition to lead (project) teams and mentor colleagues; You are proactive, communicative, responsible, and structured; Excellent language skills in English, and with preference also in Dutch, spoken and written.
Company Eurocept Pharmaceuticals is a successful Dutch company that has been active in the pharmaceutical sector since 2001.
The company is characterized as a medium-sized business with short communication lines between various departments.
Their mission is to bring medicines to the market that facilitate the therapeutic relationship between healthcare providers and patients.
The head office is located in Ankeveen, with offices in Paris and Istanbul.
Depending on the market and the services provided, Eurocept Pharmaceutical Holding also operates under the well-known brand Lucane Pharma, primarily for rare disease indications.
Depending on the product, Eurocept Pharmaceuticals acts as a marketing authorization holder, manufacturer, local representative, distributor, or wholesaler.
In all these different areas, Eurocept Pharmaceuticals delivers high-quality products and services while meeting the high expectations of customers and the requirements as laid down in regulations (GMP/GDP).
As a wholesaler and manufacturer, the company is responsible for regulatory affairs, quality, pharmacovigilance, production, marketing, sales, and distribution of medicines in many countries worldwide.
Eurocept Pharmaceuticals values diversity, and their work environment can be described as informal, dynamic, and entrepreneurial.
Interested?
Send your CV and motivation letter, mentioning reference number WS/24-282, to Bjorn Schouten at .
For more information, you can call, text, or WhatsApp Bjorn Schouten at .
An individual assessment is part of the selection procedure.
Our client has chosen Derks & Derks B.V. as the recruitment agency for this position.
Therefore, we kindly ask you to send all applications or other responses to Derks & Derks.
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