10! The number of potential blockbuster launches planned in the next two years.

10! The number of potential blockbuster launches planned in the next two years. As a member of the Regulatory Affairs team in Norway, you will get the opportunity to work in a dynamic department with great colleagues and bring new medicines to pa-tients in Norway.

We are looking for a temporary Regulatory Affairs Manager for human medicines. Novartis Healthcare A/S has a wide portfolio with both new and established medi-cines products and you will be responsible for all aspects of regulatory work for a de-fined part of the portfolio. You will work with CP, MRP and national approved prod-ucts. The job will among others include submission of variation, translation of product information, update of packaging material and work with and support Novartis global Regulatory Affairs. You will work with cross functional teams and collaborate with marketing, market access, QA and supply

Your responsibilities include but not limited to:

• High-quality and timely Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA) and variations.

• Maintain established products according to global and local regulatory plans: Trans-lation of SmPCs and leaflets and update of regulatory databases within given time-lines.

• Build and keep a highly professional relationship with the Norwegian Medicines Agency (NoMA) and handle health authority request.

• Support and interact with global regulatory affairs, logistics, QA, Market Access, marketing to best support local and global strategy for development projects and mar-keted products and ensure adequate communication with relevant stakeholders.

What you’ll bring to the role:

• University degree in medical, pharmaceutical or biological science.

• Fluent in Norwegian (written and oral). Excellent medical English and Norwegian.

• Preferably 1-2 years of regulatory experience in the pharmaceutical industry or with Health Authorities.

• IT literacy (MS Office package).

• Strong oral and written communication skills.

You’ll receive:

Competitive salary, annual bonus, pension scheme, health insurance, great colleagues and being part of a team, flexible working opportunities

We kindly ask you to apply with an English version of your CV and if shortlisted you can expect a call from an international number. If you have additional questions regarding this position, please contact Head of Regulatory Affairs Denmark, Linda Søgaard +45 51 56 08 76 .