Regulatory Affairs Specialist-Licensing (Poultry) Boxmeer • MSD Nederland

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Job Description

Join Our Team and Shape the Future of Animal Health!

Are you passionate about regulatory affairs and eager to contribute to the well-being of animals? At Global Regulatory Affairs (GRA) Boxmeer we are looking for a

Regulatory Affairs Specialist - Licensing (Poultry)

Welcome in our team

At Global Regulatory Affairs (GRA), we manage the licensing and maintenance of pharmaceutical and biological animal health products worldwide, We prepare high-quality dossiers and renewal packages for new and existing products while ensuring compliance with regulatory requirements across departments.

Our teams manage all regulatory aspects of their product portfolios, focusing on vaccines, with responsibilities including new product registration, regulatory maintenance, lifecycle management, and project timeline coordination. We also engage in industry groups to influence future veterinary legislation. We seek motivated professionals committed to advancing innovative and safe biological products for animals.

Purpose of the role

The Specialist – Licensing will join the RA Poultry species team within Global RA Biologicals, which includes dedicated teams for swine/aqua and companion animal/ruminants.

In this role you will support licensing activities for new registrations and lifecycle management, ensuring efficient licensing processes and regulatory compliance. Your primary focus will be on regulatory submissions and maintenance of our poultry portfolio in markets outside the EU, acting as a critical regulatory interface with agencies, regional coordinators, manufacturing divisions, and relevant departments.

Key responsibilities

·Act as the primary contact within GRA for Country Operations Regulatory Affairs (CORAs) and facilitate communication between RA product managers and CORAs.

·Maintain strong relationships with internal contacts (Product Managers, Operations, Pharmacovigilance) and external stakeholders (3rd party CORAs, Dutch Ministry).

·Manage the submission of dossiers and variation packages to CORAs and regulatory authorities, ensuring timely follow-up and availability of required documents and materials.

·Prepare and submit high-quality responses to regulatory authorities' inquiries during licensing processes, ensuring adherence to licensing strategies.

·Communicate updates on marketing authorizations and regulatory commitments to stakeholders and maintain accurate data in GRA information systems.

·Contribute to multi-disciplinary project teams for new product registrations and licensing strategy design, while also participating in changes in registration requirements and supporting document management initiatives.

Your profile

·Bachelor’s degree or equivalent in Veterinary, (Bio) Chemistry, Biology, or Biomedical fields, or demonstrated skills and experience at this level.

·1 to 3 years of experience in (veterinary) regulatory affairs, preferably within veterinary biologicals.

·Proficient in English, with strong oral and written communication skills.

·Detail-oriented, efficient, flexible, and able to work under pressure while maintaining a service and compliance mindset.

·Knowledge of country-specific licensing requirements and general product development processes, with the ability to analyze and propose solutions to licensing issues.

·Proficient with information systems and capable of training colleagues with limited support, while contributing to the improvement of internal processes.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive

·Competitive salary

·35,5 days of leave

·Attractive collective health care insurance package with considerable reduction rates

·Solid Pension Plan

·Bonus plan subject to the company annual results

·Flexible working arrangements

Animal Health Division

Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society and our planet. We offer one of our industry’s most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species.

For questions about this vacancy

Please send an email including the vacancy number and job title to the following email address: via de button "Solliciteer nu" op deze pagina.

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Requisition ID:R349014