Specialist, Regulatory Affairs

Job Description

Did you always want to work in a company where your work can have a real impact? Do you enjoy working in an international environment with lots of room for personal development?

We have an exciting opportunity at the Boxmeer facility for a:

Specialist, Regulatory Affairs (Poultry)

Welcome in our team

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. These teams hold end-to-end responsibility for regulatory aspects of their product portfolios, primarily focusing on vaccines. Key responsibilities include new product registration, regulatory maintenance, and lifecycle management, alongside managing project timelines and ensuring timely collaboration with other GRA teams.

As a Licensing Specialist, 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 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

• HBO 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 : RecruitmentNL@MSD.com

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:

04/30/2025

*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: R326708