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MSD

Senior Regulatory Affairs Specialist

MSD

. Lead and coordinate new marketing authorization applications for veterinary medicinal products and line extensions .

Posted 11/6/2026full-timeStockholm • SwedenSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in Regulatory Affairs and Quality Management Systems, with a strong focus on managing marketing authorization applications and compliance with local and global regulations. Proficient in stakeholder communication and documentation preparation in both Swedish and English.

Highest-signal resume keywords
Regulatory Affairs ExperienceQuality Management SystemsPharmacovigilance KnowledgeMaster's Degree in Pharmacy or Life SciencesStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory Documentation PreparationAdverse Event ReportingProduct Quality Complaint HandlingSPC DevelopmentLabeling and Packaging MaintenanceRegulatory Variations SubmissionQuality AssuranceTranslation and ProofreadingInspections SupportRegulatory Intelligence
Soft Skills
Strong Planning SkillsOrganizational SkillsProblem-Solving CapabilitiesAttention to DetailTeam Collaboration
Industry Keywords
Veterinary Medicinal ProductsPharmaceutical IndustryAnimal Health IndustryMedicinal AuthoritiesQuality AuditsStandard Operating Procedures

About the role

Key responsibilities & impact
  • Lead and coordinate new marketing authorization applications for veterinary medicinal products and line extensions
  • Prepare and submit regulatory variations in 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
  • Serve as the Quality Responsible Person for the Swedish legal entity
  • Maintain and improve Quality Management Systems and Standard Operating Procedures
  • Act as key contact and representative toward Medicinal Authorities
  • Support inspections and quality audits
  • Contribute to regulatory intelligence and implementation of regulatory requirements

Requirements

What you’ll need
  • 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
  • Ability to manage multiple priorities in a fast-paced environment
  • 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
  • Ability to work independently and as part of a team
  • Must submit CV and application in English

Benefits

Comp & perks
  • 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 teamwork
  • Professional development opportunities within a leading global healthcare company
  • The chance to contribute to improving animal health and sustainable food production worldwide