Global Regulatory Affairs Coordinator

Location: Boxmeer, Noord-Brabant  |  Sector: Pharmaceuticals  |  Start Date: 11/3/2023  |  Job ref: 51777

The Company
Our client, based in Boxmeer, is the largest innovative pharmaceutical company in the Netherlands. Their mission is to become a global leader in generics and medicines that contribute to the well-being of animals around the world.

Role Description
Your role will involve joining a project team dedicated to the revision of product information for all biological products authorized in the European Union, as mandated by the New Veterinary Regulation. Your primary focus will be on crafting the necessary content for regulatory submissions. Moreover, you will offer assistance in the licensing of new products and the regulatory upkeep of existing biological products.

-Creates and oversees the timely submission of high-quality scientific dossiers to facilitate the efficient licensing of new products and the upkeep of existing ones.
-Prepares and manages the timely submission of high-quality responses to queries posed by regulatory authorities during the licensing process.
-Participates in meetings with regulatory authorities to discuss both regulatory and technical aspects related to new submissions and addresses questions that arise during licensing proceedings.
-Develops and maintains an extensive understanding of all pertinent regulatory prerequisites.
-Assists in shaping regulatory strategies for both emerging and established biological products.

-Educational background, ideally with a Ph.D. or equivalent experience in biomedical fields like virology, bacteriology, molecular biology, or veterinary sciences.
-At least 5 years of experience in the veterinary pharmaceutical sector.
-Proficiency in both spoken and written English, showcasing excellent writing skills.
-Demonstrates strong interpersonal and negotiation skills.
-Possesses adaptability and perseverance, with a commitment to service and compliance.
-Displays a keen eye for detail.

Other information
We are currently seeking highly motivated talents to join ours clients on an exciting journey. Our client is looking for people to fill various positions within their organization. If you are interested in this opportunity, or if you know of someone who may be, please do not hesitate to contact me through the apply button. I would be more than happy to discuss the details of this opportunity with you and explore the potential for your professional growth with our client.

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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.

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