Job Description
Join a Global Leader in Animal Health
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.
Key Responsibilities
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
What We Are Looking For
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.
Why Join our company?
At our company, you will become part of a collaborative Nordic team and a global organization driven by innovation, scientific excellence, and a passion for improving animal health.
We offer:
A broad and impactful role with significant responsibility
Opportunities to collaborate with international experts and stakeholders
A supportive and inclusive working environment built on trust, engagement, and…