MSD Regulatory Affairs Specialist-Licensing Poultry 

Netherlands, North Brabant 

378023071

Job Description

Regulatory Affairs Specialist - Licensing (Poultry)

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

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.

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

Flexible working arrangements

For questions about this vacancy

Please send an email including the vacancy number and job title to the following email address:

Current Contingent Workers apply

Project Temps (Fixed Term)

Adaptability, Business, Communication, Detail-Oriented, Electronic Common Technical Document (eCTD), Employee Training Programs, Global Regulatory, Licensing, Management Process, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Product Registrations, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting, Regulatory Requirements, Regulatory Strategy Development, Regulatory Submissions, Technical Writing

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