Regulatory Affairs Specialist in Søborg, Denmark
Regulatory Affairs Specialist
Date: Nov 24, 2022
Location: Søborg, DK, 2860
Company: Teva Pharmaceuticals
Why join Teva?
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
What will you do?
We are currently recruiting for a position within our Regulatory Affairs team covering Denmark, Norway and Iceland. You will be responsible for your own product portfolio and work with all aspects of bringing and maintaining a medicinal product on the market.
You will be part of a highly engaged and divers RA team of 10 people and report directly to the Head of RA in Denmark. You will work closely with our Nordic RA colleagues as well as European Regulatory Affairs teams. Teva is a wellbeing oriented organization, and our working atmosphere is pleasant and informal - this is directly reflected in the way we support each other to reach common goals.
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, in order 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 to Life Cycle Management changes; e.g. requesting, proof reading and approving artworks
Making sure, 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 portfolio, supply chain, Medical Affairs, QA and PV
Prioritize, plan and monitor allocated projects against the defined timelines
Keeping up to date with EU regulatory guidelines and local requirements
Act as RA support to our commercial business.
Who Are You?
You have a master's degree in pharmacy, pharmaceutical sciences or related field. Because of the complexity and the big number of different medicines Pharmacy would be considerate the best match :)
On top of this you will bring some experience within the pharmaceutical industry or Health Authorities within a Regulatory, Compliance or related position.
You will bring some experience and knowledge of European Regulatory Affairs legislation/guidance and have the ability to communicate at all levels within the organization.
You are fluent in Danish and English; any other language will be a plus.
For sure you are a positive, driven and enthusiastic person with the willingness and desire to grow and develop. We will help you grow!
In this role it helps when you have a strong attention to detail and a high level of structure as well as a strong ability to organize, prioritize and cope with tight deadlines
What will we offer?
Vacation leave according to The Danish Holiday Act
5 extra holiday entitlements
Bonus based on personal and company result
Collective health insurance
Flexible working conditions with hybrid working policy
A very diverse International team
Head of Regulatory Affairs DK/IS/NO
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
EOE including disability/veteran