Regulatory Affairs Specialist to Oriola

Oriola’s 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.
You understand the consultancy business and are sales-orientated and eager to help us to expand our Regulatory Affairs business in Nordics. The permanent position is preferably based in either Uppsala or Stockholm. For the right candidate, other locations in Sweden will also be considered. We evaluate candidates continuously and welcome your application today!

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:
- A minimum of eight 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. If our values resonate with you and you are interested in the position, apply today!

ABOUT ORIOLA

Oriola is a specialist in pharmaceutical distribution and pharmacy services, focusing on the best service and quality on the market. Our purpose, “Health for Life”, reflects what we want to achieve together with our customers. Oriola's Expert Services provides a range of strategically important services to the pharmaceutical industry and healthcare, such as Patient Support Programs, Medical Information, Pharmacovigilance and Regulatory Services.
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. Oriola Corporation is listed on Nasdaq Helsinki. www.oriola.com