Merck

Senior Regulatory Affairs Specialist

2 Locations
Full-time
Posted Nov 6, 2026

Apply on employer site

Skills

Quality Management Systems

Job description

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 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

For further information about the position, please contact:

Nina Hyldgaard Director, Regulatory Affairs, Nordics 45 40 45 19 77

Please submit your CV and application in English as soon as possible.

Applications will be reviewed on an ongoing basis.

Application deadline: December 15, 2026.

Additional location(s) Compensation Information:

Required Skills:

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

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/15/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.