Regulatory Affairs Associate Nordics (M/F)
MAIN PURPOSE:The Regulatory Affairs Associate Nordics is responsible for assisting the Regulatory Affairs Department in Denmark, Sweden, Norway, Finland and occasionally Iceland.
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
- Prepare and submit high quality regulatory submission documentation following current best practice for the Nordics countries
- Liaise with relevant internal departments and external contacts to ensure regulatory requirements for submissions are met, and communicate with regulatory authorities in order to expedite approval of submissions, both independently and as directed by line manager
- Participate as appropriate in project teams
- Identify, provide and insert information in the regulatory databases, such as XeVPMD and Veeva
SKILLS & KNOWLEDGE
- Candidate with a Pharma-related degree, or equivalent relevant experience (Medical, Science, Legal)
- Qualification and experience as required by applicable codes
- Excellent verbal and written communication skills in English and at least one Nordic language, as well as Finnish if possible
- Knowledge and up to date in local/European legislation and guidelines (DK, FI, NO, SE, EU). Knowledge and skills will be maintained by appropriate updates and training
- High standard of customer service, follow up on commitments and requests
- Demonstrates a good ability to analyse data
- A good knowledge of quality management systems
- Awareness, understanding and an ability to pragmatically interpret GxP requirements relevant to responsibilities
Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2017, Norgine’s total net sales were EUR 345 million, up 17 per cent.
Norgine employs over 1,300 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.
Norgine specialises in gastroenterology, hepatology, cancer and supportive care.
Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France.
For more information, please visit www.norgine.com
In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com