Senior Regulatory Affairs Specialist

MSD Sverige; Stockholms kommun; Hybrid; SEK 900,000 - 1,200,000; Full time

Benefits offered by this job

Broad role

International collaboration

Professional development opportunities

Inclusive, collaborative culture

Job summary

MSD Sverige AB in Sweden seeks a Senior Regulatory Affairs Specialist to lead veterinary regulatory submissions, lifecycle activities and pharmacovigilance for animal health products. You will serve as Quality Responsible Person and collaborate with Nordic and global teams to ensure compliance and successful registrations.

The role emphasizes strategic regulatory oversight, quality management and ongoing liaison with authorities, with hybrid work arrangements and opportunities for professional

Qualifications

• Experience in Regulatory Affairs, Pharmacovigilance, or Quality Assurance in pharma/animal health.
• Strong planning, organization and stakeholder management skills.
• Excellent written skills in Swedish and English; translations/regulatory documentation a plus.

Responsibilities

• Lead regulatory submissions for veterinary medicinal products and line extensions.
• Coordinate variations and ensure compliance with local and global requirements.
• Develop, review and maintain product information, SPCs, labeling and packaging.
• Act as liaison with Nordic and international Regulatory Affairs, PV and Quality teams.
• Manage adverse event reporting and quality complaint handling per regulations.
• Serve as Quality Responsible Person for the Swedish entity.
• Support inspections, audits and regulatory intelligence initiatives.

Skills

Regulatory Affairs

Pharmacovigilance

Quality Assurance

Education

MSc in Pharmacy, Veterinary Science, Life Sciences or related

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?

Job Description

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

• 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

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

Additional Information

Nina Hyldgaard Director, Regulatory Affairs, Nordics [phone]

Application deadline December 15, 2026.

Employee Status

Regular

Flexible Work Arrangements

Hybrid

Adverse Events, Animal Health Care, Audits Compliance, Dossier Submissions, Drug Regulatory Affairs, Pharmaceutical Regulatory Affairs, Pharmaceutical Regulatory Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions