Regulatory Affairs Associate- 12 Month Fixed-Term Contract

Teva Pharmaceuticals

18h

About The Position

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.We would like to invite applications for the role of Regulatory Affairs Associate covering the Norweigen market.

Requirements

Bachelor’s or master’s degree in pharmacy or equivalent
Written and verbal proficiency in Norwegian and English language
Positive drive and enthusiasm with a willingness and desire to grow, learn and develop
Attention to detail and high level of structure and accuracy
Strong ability to organize, prioritize and cope with tight deadlines
Ability to communicate at all levels within the organization, locally and internationally

Nice To Haves

Preferably experience from working with Regulatory Affairs in the pharmaceutical industry or with Health Authority
If so, experience within a variety of Regulatory Affairs tasks such as working with both nationally and MRP, DCP, CP approved products

Responsibilities

Being regulatory responsible for assigned products in Denmark, Norway and Iceland.
Support the process for new MA applications in DK/IS/NO, in cooperation with our launch coordinator.
Preparation and submission of Life Cycle Management Changes for national procedures (variations, renewals, etc.) including creation of national texts, to comply with regulatory requirements
Preparation and submission of variations following CCSI updates.
Translation and proof reading of regulatory texts in local language.
Preparation and submission of responses to Regulatory Authorities.
Responsible for changes in packaging material, in connection with Life Cycle Management changes e.g. requesting, proof reading and approving artworks.
Ensure, corporate regulatory data and document management systems are up to date.
Interaction with local Health Authorities in Denmark, Norway and Iceland.
Coordination with other functions like supply chain, Medical Affairs, QA, PV and commercial teams.
Prioritize, plan and monitor allocated projects against the defined timelines.
Keeping up to date with EU regulatory guidelines and local requirements