Senior Specialist Global Regulatory Affairs

About the role

As a Senior Specialist Regulatory Affairs Product Manager you will be part of one of the Regulatory Affairs (RA) Product Manager teams within GRA Biologicals. These teams have end-to-end responsibility for the regulatory aspects of a selected species-based subset of the biologicals portfolio, including new product registration and regulatory maintenance of recently registered products. In this role, you will help to drive new licensing and lifecycle management activities from a regulatory perspective to support efficient product registration, portfolio maintenance and compliance. You will act as a point of contact for internal stakeholders such as R&D, Manufacturing and Commercial and participate in meetings with external stakeholders, including competent authorities. Global Regulatory Affairs Biologicals offers a challenging environment where you can broaden your skills as a regulatory affairs professional or further develop them. Tasks and responsibilities include but are not limited to Prepare and manage analytical and scientific content for new product licensing and maintenance of existing products, with a focus on safety and efficacy. Respond to questions from regulatory authorities during licensing procedures. Participate in meetings and videoconferences with authorities on technical and regulatory topics. Develop and maintain strong knowledge of relevant regulatory requirements. Support regulatory strategies for new and existing biological products. Participate in multidisciplinary product development and maintenance teams to ensure: relevant regulatory requirements are understood and followed across our Company product development and maintenance are aligned with applicable regulatory requirements. Provide input on future regulations, pharmacopeial monographs and guidelines. Your profile University degree or HBO Bachelor's degree (or equivalent) preferably in Veterinary Science, Veterinary Medicines, Chemistry, Biology or Biomedical Sciences. A degree in Veterinary Science or Veterinary Medicines is considered an asset. Experience in veterinary regulatory affairs, preferably in biologicals, is an asset. Excellent spoken and written English, with strong professional writing skills. Accurate, efficient, pragmatic, flexible, service-oriented, and compliance-minded, with the ability to work under pressure and strong cultural awareness. Strong communication skills, with the ability to explain complex information clearly. Strong team-player skills. Ability to identify licensing issues, analyze them, and propose solutions. Good understanding of internal processes and a willingness to improve them. Full proficiency with information systems.

Benefits

Additional Information

Job Description Make your mark on global animal health and step into a role where your regulatory expertise drives innovation, ensures compliance, and brings impactful solutions to markets worldwide. Join our team in Boxmeer as a: Senior Specialist Global Regulatory Affairs Welcome in our team Global Regulatory Affairs (GRA) is responsible for licensing and maintaining pharmaceutical and biological animal health products worldwide. Within this function, GRA Biologicals manages the biological product portfolio and supports the full product lifecycle. The team prepares registration dossiers, variations and renewals for new and existing products, while providing regulatory expertise to ensure requirements are understood and applied across Animal Health. It also develops regulatory strategies, supports the portfolio in the marketplace by advising stakeholders, maintains relationships with regulatory authorities and contributes to industry expert groups shaping future veterinary legislation and guidelines.

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