Senior Regulatory Affairs Specialist

Job Description

Are you looking for a broad and impactful role where you can make a real difference in animal health? Do you thrive in a dynamic environment where Regulatory Affairs, Pharmacovigilance, and Quality intersect?

Our company is seeking an experienced and motivated Senior Regulatory Affairs Specialist to join our Nordic Regulatory Affairs team in Sweden. This is a unique opportunity to play a key role in ensuring the successful registration, maintenance, safety monitoring, and quality compliance of our Animal Health medicinal products.

In this diverse and highly visible position, you will be responsible for managing regulatory submissions and product lifecycle activities, pharmacovigilance reporting, and serving as the Quality Responsible Person for our Swedish legal entity. You will collaborate closely with Nordic colleagues as well as international stakeholders across Regulatory Affairs, Pharmacovigilance, and Quality functions, while acting as an important liaison with Medicinal Authorities.

At our company, our mission is to improve the health and well-being of animals through innovative medicines, vaccines, and solutions. As a trusted global leader in veterinary medicine, we are committed to supporting veterinarians, farmers, pet owners, and the broader food production industry by helping prevent diseases and reducing the need for antibiotics.

As a Senior Regulatory Affairs Specialist, you will:

• →Lead and coordinate new marketing authorization applications for veterinary medicinal products and line extensions
• →Prepare and submit regulatory variations, ensuring compliance with local and global requirements
• →Develop, review, translate, and maintain product information, including SPCs, labeling, and packaging materials
• →Collaborate with global Regulatory Affairs, Pharmacovigilance, and Quality teams
• →Manage adverse event reporting and product quality complaint handling in compliance with applicable regulations
• →Serve as the Quality Responsible Person for the Swedish legal entity
• →Maintain and continuously improve Quality Management Systems (QMS) and Standard Operating Procedures (SOPs)
• →Act as the key contact and representative towards Medicinal Authorities
• →Support inspections and quality audits, ensuring ongoing compliance
• →Contribute to regulatory intelligence and implementation of regulatory requirements across the business

To succeed in this role, you bring:

• A Master's degree (MSc) in Pharmacy, Veterinary Science, Life Sciences, or another relevant scientific discipline
• Experience within Regulatory Affairs, Pharmacovigilance, Quality Assurance, or a related field, preferably within the pharmaceutical or animal health industry
• Strong planning and organizational skills combined with a flexible and adaptable mindset
• The ability to effectively manage multiple priorities in a fast-paced environment
• A proactive, solution-oriented approach with strong problem-solving capabilities
• Excellent attention to detail while maintaining a broader business perspective
• Strong communication and stakeholder management skills
• Excellent written skills in both Swedish and English
• Experience with translations, proofreading, and preparation of regulatory documentation is considered an advantage
• A collaborative and positive mindset with the ability to work independently and as part of a team

Most importantly, you are someone who takes ownership, demonstrates accountability, and enjoys working together with colleagues to achieve shared goals.

For further information about the position, please contact:

Current Employees apply HERE

Current Contingent Workers apply HERE