About the Company
The company is a global leader in animal health, developing and producing vaccines, medicines, and solutions for pets, livestock, and wildlife. It operates research, production, and distribution facilities worldwide and is recognized for its science-driven innovation, commitment to quality, and focus on safety and sustainability.
Role Description
We are seeking a Regulatory Affairs Specialist with experience in biological or veterinary pharmaceuticals. In this role, you will be responsible for managing licensing procedures, dossier submissions, and variation packages, while ensuring compliance with EU regulatory frameworks, including the New Veterinary Regulation. You will play a key role in supporting regulatory strategies, submission planning, and documentation management.
Key Responsibilities
- Manage and execute licensing procedures, including dossier preparation, submissions, and variation packages.
- Ensure compliance with EU regulatory frameworks, with a focus on the New Veterinary Regulation.
- Maintain and update regulatory databases and document management systems.
- Prepare and review responses, regulatory documentation, and translations as required.
- Coordinate with internal and external stakeholders to ensure timely and accurate submissions.
- Contribute to regulatory strategy by interpreting new regulations and assessing their impact on projects.
Requirements
- Background in Regulatory Affairs, preferably within biological or veterinary pharmaceuticals.
- Hands-on experience in licensing procedures, dossier submissions, and variation packages.
- Strong knowledge of EU regulatory frameworks, including the New Veterinary Regulation.
- Proficiency in managing regulatory databases and document management systems.
- Excellent written communication skills for regulatory documentation and responses.
- Experience with translation coordination and regulatory systems is an advantage.
- Degree in Veterinary Science, Biology, Biochemistry, or a related life sciences field (HBO or university level).
- Ability to interpret new regulations, assess their impact, and contribute to submission planning and regulatory strategy.
Other information
Apply to our vacancy for more details. Looking forward to chatting with you!
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.