- Stockholm, Stockholm County, Sweden
- Full-time · Senior
Senior Regulatory Affairs Specialist responsible for managing regulatory submissions, pharmacovigilance, and quality compliance for animal health medicinal products in Sweden.
Responsibilities
- 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
Requirements
- Master's degree (MSc) in Pharmacy, Veterinary Science, Life Sciences, or another relevant scientific discipline