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 team with great colleagues and bring new medicines to patients. We believe working in RA in Novartis is a place for continuous development with good balance of strong and exciting pipeline and complexity of established products, which gives a very diverse workday and broad collaboration across functions and within RA in the Nordics.

We are looking for a new team member in Regulatory Affairs in an exciting combination of roles. Your responsibilities will be shared between Process Improvement & Excellence (PIE) and Regulatory Affairs Manager. The PIE role has a strong quality compliance profile and ensures implementation and RA compliance to quality standards, regulatory processes and systems in RA Norway and Nordics. The PIE role is part of a Novartis wide network. As RA Manager you will be responsible for all aspects of regulatory work for a defined part of the products. The job will include submission of variations, translation of product information and collaboration with Novartis Global Regulatory Affairs. As a RA Manager you will work closely with other functions.

Your responsibilities include, but not limited to:

• Ensure adherence to global and local procedures. Identify gaps in local working procedures and update and maintain local working procedures as needed. Provide input to global procedures

• Ensure maintenance and compliance of regulatory databases. Act as country SPOC for global compliance initiatives to ensure high quality regulatory data in databases.

• Manage deviations and related CAPAs and keep oversight of regulatory deviations. Support and ensure audit and inspections readiness. Support, develop and implement CAPA to address audit/inspection findings.

• High quality and timely Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA) and line-extensions and maintain established products according to global and local regulatory plans and procedures. Handle Health Authorities requests.

• Translation of SmPCs and leaflets within given timelines and update and maintain regulatory databases. Initiate and review of artwork, RA approval of promotional material

• Support and interact with Global Regulatory affairs, Supply Chain, QA, Market Access, Marketing (project and product teams) and Sales to best support local and global strategy and interest for development projects and marketed products and ensure adequate communication with relevant stakeholders.

What you’ll bring to the role:

• University degree (Master level or more) in medical, pharmaceutical or biological science.

• Preferably, 2-3 years of quality and/or regulatory affairs experience in the pharmaceutical industry or with Health Authorities.

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

• IT literacy (MS Office package).

• Strong oral and written communication skills.

• A quality mind-set, curiosity, learning agility and collaboration skills

Desirable requirements:

• strong personal drive, independent and with a strong team spirit

• flexible but persistent and a solution oriented mind with attention to details

• positive mind-set and ability to multitask without losing either the big picture or deadlines - even when things go fast

You’ll receive:

Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.

Why consider Novartis?

799 million. That’s how many lives our products touched. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

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 Norway, Helga G. Brøto +47 91 88 70 95.

We would like to receive your application as soon as possible and 05-May-2021 at the latest.