Regulatory Affairs Specialist

Stockholm


Oriola is a health and wellbeing company operating in the Nordic countries - Our Purpose is Health for Life and we are now strengthening our organisation!


About Oriola
We help people to live healthier lives by giving them access to sustainable health and wellbeing products and services. In Sweden, Oriola owns the country’s third-largest pharmacy chain, Kronans Apotek. In addition to pharmacies, our dose-dispensing, medical information and patient support services, we enhance the safety and effectiveness of pharmaceutical care. Our expert services support pharmaceutical companies throughout the entire lifecycle of medicines. Oriola’s supply chain ensures reliable and safe delivery of pharmaceuticals to pharmacies, hospital pharmacies, veterinarians and other healthcare operators. In 2019, Oriola Corporation’s net sales were 1.7 billion euros and we employed nearly 4,300 professionals. Oriola Corporation is listed on Nasdaq Helsinki. www.oriola.com

Our Regulatory Affairs and Translations department is now looking to recruit a Regulatory Affairs Specialist to our Nordic Team to Sweden.
Oriola is a health and wellbeing company operating in the Nordic countries and the Regulatory Affairs and Translations Team offers regulatory affairs management and translations services to our customers. In this stimulating role you will have the opportunity to work daily with our customers, apply your expertise to help tackle challenges in regulatory matters and act as an intermediary between our customers and the relevant regulatory authorities.

You will work both independently and in close collaboration with Oriola’s Nordic Regulatory Affairs and Translations team and help us to expand our Regulatory Affairs business in the Nordics.

About the position

Main responsibilities include:

– Facilitate marketing authorisation applications and maintenance (e.g. variations, renewals, transfer applications and OTC applications) for human and veterinary medicines
– Delegation, execution and follow-up of the customer assignments
– Participation in the selling and development of the regulatory affairs service in Sweden/Nordics together with the Head of Regulatory Affairs and Translations
– Consultation and training

Qualifications

To succeed in this role, you should have the following skills and experience:
– 3-5 years of experience in regulatory affairs
– A degree in pharmacy or another relevant scientific field
– Strong competence and knowledge of different authorisation routes, marketing authorisations and the related submissions e.g. variations, notifications and renewals, and product information documents and basic knowledge of pharma etihical rules
– Strong competence and knowledge of the legislation, regulations and guidelines for regulatory affairs in the EU and other relevant territories
– Customer-oriented
– Proactive and capable of working closely with the customers
– Precise and quality-oriented
– Fluent in Swedish and English

We are ready to offer you an interesting and stimulating role in our Nordic Regulatory Affairs and Translations Team. At Oriola, we take responsibility, we are open, we work together, and we take initiative. 

For this recruitment we are working together with Poolia Life Science. Apply at their website here!

Contact person