Senior Specialist Global Regulatory Affairs

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.

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.

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, and the summary below will give you an idea of what you can expect.

• Competitive salary and a 3% year-end allowance;
• 35,5 days of leave;
• Attractive collective health care insurance package with considerable reduction rates;
• Solid Pension Plan;
• Annual bonus based on own and company performance;
• Travel allowance for commuting;
• A high‑quality company restaurant offering fresh and healthy options every day.
• Excellent accessibility: the train station is located directly next to our main entrance, and there is ample parking available.
• A contribution toward your personal sports membership to support your vitality.
• A beautiful private park on site - perfect for a walk, a break or a moment of relaxation.
• Mental well‑being support through Lyra Health for you and your family members.
• Access to a dedicated prayer/meditation room.
• Extensive growth opportunities thanks to the size of the site and the wide range of disciplines and global departments represented in Boxmeer.

Animal Health

Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. 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.

Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

For questions about this vacancy

Please send an email including the vacancy number and job title to the following email address: RecruitmentNL@MSD.com .

Required Skills:

Immunology, Regulatory Experience, Regulatory Submissions, Scientific Writing, Vaccinology

Preferred Skills:

Biomedical Sciences, Product Development, Veterinary Medicine

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/6/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R401611