Regulatory Affairs Senior Specialist – Licensing (Poultry)

Job Description

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Are you passionate about regulatory affairs and eager to make a significant impact in the animal health sector? We invite you to explore an exciting opportunity at our office in Boxmeer for the position of:

Regulatory Affairs Senior Specialist – Licensing (Poultry)

Welcome in our team

Global Regulatory Affairs (GRA) is accountable for licensing and maintaining pharmaceutical and biological animal health products globally. GRA Biologicals is a part of this department and responsible for the licensing of new biologicals (mainly vaccines) and the regulatory maintenance of the existing portfolio worldwide except the US.

GRA Biologicals is divided in species teams that handle specific groups of animals: poultry, aqua/swine and ruminants/companion animals.

Purpose of the role

As a Senior Specialist - Licensing you will work with the team responsible for the licensing aspects of regulatory submissions of the biologicals product portfolio. You will act as a key regulatory interface between regulatory authorities, country operations Regulatory Affairs (RA), regional coordinators and relevant company departments. This role mainly focuses on EU and the Senior Specialist has the responsibility to manage and keep full oversight of all licensing activities for biological products, and to develop optimal submission strategies for licensing of new products as well as regulatory maintenance of existing products. You will work in close collaboration with other RA Licensing managers and RA product managers, who are responsible for the technical content of regulatory submissions and will interact directly with the competent authorities.

Tasks and responsibilities include, but are not limited to

• Serve as the primary point of contact within GRA Biologicals for local Country Operations (CORA) and regulatory authorities, facilitating communication between RA product managers and national competent authorities.
• Prepare and manage timely submission of high-quality documentation packages, e.g., responses to authority questions, and you are responsible for all licensing (procedural) questions.
• Initiate and conduct standard and complex licensing procedures, ensuring compliance with regulatory requirements.
• Provide guidance and training on licensing procedures to less experienced staff, fostering their professional development.
• Engage directly with national competent authorities to discuss procedural and content aspects of regulatory submissions.
• Support the fulfillment of regulatory commitments established during licensing procedures.
• Contribute to the design of effective regulatory submission strategies for licensing processes, in close collaboration with CORA and other stakeholders.
• Collaborate in multi-disciplinary project teams, offering licensing expertise for new product registrations and ongoing product maintenance.
• Stay informed on emerging licensing requirements and guidelines, assessing their potential impact on product development and regulatory timelines.

Your profile

• University degree or HBO Bachelor in Veterinary, (Bio) Chemistry, or Bio-Medical fields.
• Preferably 3 to 5 years in regulatory affairs, ideally with (veterinary) biologicals.
• Excellent oral and written English skills with strong writing abilities.
• Accurate, efficient, and pragmatic, with a strong service and compliance mindset.
• Exceptional ability to convey information clearly and persuade others in straightforward situations.
• Strong team player with the ability to work under pressure and adapt to changing circumstances.
• Skilled in identifying and analyzing licensing issues, proposing solutions based on standard procedures.
• Understanding of licensing requirements and internal processes, with the ability to contribute to enhancements and train colleagues.

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

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):

Required Skills:

Adaptability, Adaptability, Audits Compliance, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Immunochemistry, Information Systems, Maintenance Management, Management Process, Mentorship, Microbiology, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Physiology, Process Improvements, Product Development, Project Management, Quality Control Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Management, Regulatory Operations {+ 3 more}

Preferred Skills:

Job Posting End Date:

06/26/2025

*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: R351645