Regulatory Affairs Manager
Regulatory Affairs Manager
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Job Description
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
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 teams goals.
Who You Are
You hold a Masters degree in pharmacy pharmaceutical sciences or a related field.
You bring ideally 23 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.
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Manager
Employment Type
Full-Time
