Regulatory Affairs Manager at Roche

Would you like to be part of an active and flexible organization and have responsibilities within Drug Regulatory Affairs? Roche Norge AS is looking for a committed and energetic Regulatory Affairs Manager with a structured and quality-oriented mindset.

As Regulatory Affairs Manager, you will play a key role in managing the lifecycle of Roche products in Norway, ensuring compliance with both EU and national legislation. You will collaborate closely with local and global teams, act as a trusted partner to stakeholders, and contribute to the successful delivery of healthcare solutions. This is a unique opportunity to combine your scientific expertise with regulatory knowledge in an impactful role.

The Opportunity

• Manage and maintain Marketing Authorizations for medicinal products registered via centralized and national procedures in Norway, ensuring timely regulatory submissions and updates.

• Implementing and maintaining product artworks, securing accurate translations of regulatory texts into Norwegian.

• Manage Standard Operating Procedures (SOPs) and instructions related to regulatory tasks.

• Serve as the main point of contact with the national authority on regulatory matters for assigned products.

• Support commercial teams and headquarters with relevant regulatory insights and activities.

• Stay up to date with national and Roche standards, ensuring continuous training and compliance.

• Be part of the “License to Operate” team in Roche Norge AS and contribute to the team’s goals.

Who You Are

• You hold a Master’s degree in pharmacy, pharmaceutical sciences, or a related field.

• You bring ideally 2--3 years of experience in the pharmaceutical industry, with knowledge or training in Drug Regulatory Affairs.

• You are systematic, flexible, and thrive in a regulated environment while building strong networks across teams.

• You are fluent in written and spoken Norwegian and English.

• You act with integrity, demonstrate agility, and combine independent working with effective collaboration.