Regulatory Affairs Specialist – Nordic Markets

About the role

PLG is looking for a motivated and detail‑oriented Regulatory Affairs Specialist to support its Nordic portfolio. The role covers the full product lifecycle, from initial registration to post‑approval maintenance, with exposure to other EU markets.

Key responsibilities

• Prepare, compile and submit Marketing Authorisation Applications (MAA) and variations for Nordic and assigned EU countries.
• Manage post‑approval activities such as variations, renewals, product information updates and artwork review.
• Monitor national and European regulatory requirements, ensure compliance with client‑specific procedures and support audit readiness.
• Act as a primary contact with Health Authorities, handling queries and maintaining professional communication.
• Use regulatory and document management systems (e.g., Veeva Vault, LorenZ, TrackWise, PromoMats) to track submissions, maintain databases and ensure accurate time‑tracking.

Required profile

• Degree in Pharmacy, Biology, Chemistry or a related life‑science discipline.
• 2‑5 years of regulatory affairs experience, with strong knowledge of Nordic regulations.
• Proven experience across product lifecycle management, including new MAAs, variations, orphan drugs and line extensions.
• Experience interacting with Health Authorities and working in a consultancy or multi‑client environment is an advantage.
• Excellent organisational and communication skills, proactive mindset and ability to work autonomously and in teams.

Required skills

• Microsoft Office Suite
• Veeva Vault or comparable EDMS
• LorenZ
• TrackWise
• PromoMats