Regulatory Affairs Manager Novartis

Regulatory Affairs Manager

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 patients.

We are looking for a Regulatory Affairs Manager for human medicines. Novartis Norge has a wide portfolio with both new and established medicines products and you will be responsible for all aspects of regulatory work for a defined part of the products. You will work with CP, MRP and national approved products. The job will among others include submission of variation, translation of product information and work with and support Novartis global Regulatory Affairs. You will be part of cross functional teams and have close collaboration with marketing during registration of new medicinal products and maintenance of existing marketing authorizations.

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 line-extensions.
• Maintain established products according to global and local regulatory plans.
• Translation of SmPCs and leaflets within given timelines. • Update and maintain regulatory databases. • Timely submission and tracking of Risk Management and educational material. • Handle Health Authorities requests. • Initiate and review of artwork. • Build and keep a highly professional relationship with the Norwegian Medicines Agency (NoMA). • Facilitate scientific advice meetings with (NoMA) for new products and projects in defined therapeutic area. • Participate in assigned DRA sub-teams representing the defined region. • Support and interact with global regulatory affairs, local Trial Monitoring Organization (TMO), logistics, 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. • Contribute in Pharma Compliance Clearance Committee. • Monitor future trends in regulatory issues which are likely to affect Novartis interest. Share information with colleagues and HQ if appropriate.

What you'll bring to the role:

• University degree in medical, pharmaceutical or biological science.
• Excellent medical English and excellent medical Norwegian.
• Preferably 2-3 years of regulatory experience in the pharmaceutical industry or with Health Authorities. • IT literacy (MS Office package). • Strong oral and written communication skills.

The job in Regulatory Affairs requires that you:

• Work independently.
• Pay attention to details.
• Is flexible but persistent and take the initiative to get the job done. • Have a positive approach to life and manages to keep many balls in the air without losing either the big pictures 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.

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, Kamilla Jendem Logg inn for å se kontaktinformasjon.

Deadline for applications - 10.05.19

Why Novartis

927 million. That's how many lives our products touched in 2017. 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.

We are Novartis. Join us and help us reimagine medicine.