PharmaLex is looking for a Regulatory Affairs Specialist fluent in Finnish
We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Are you experienced in Regulatory Affairs and have the desire to work as a consultant?
Then, PharmaLex is your career opportunity. Our Nordic Regulatory Affairs team is growing, and we are looking for a new office based or remote team member with fluency in Finnish.
- Planning and conducting authorization procedures in the EU (MRP, DCP, CP and purely national procedures) and in emerging markets as well as lifecycle management procedures (variations, renewals, MAH transfers, etc.) worldwide
- General guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labelling
- Participation in the preparation, revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling)
- Communication with the client and the Health Authorities
- Translation of Finnish texts
- University degree (MSc) in pharmacy or other natural sciences
- Proven experience in evaluation, preparation and compilation of quality documentations and/or experience in regulatory processes (registration procedures, renewals, variation procedures)
- Ability to implement tactical goals of customer or internal projects within daily work
- Structured, analytical, systematic and independent manner
- Capability of supervision, prioritization and processing of parallel projects and tasks
- High service orientation
- Ability to manage internal and external (client) relationships on operational as well as client’s team lead level
- Excellent team player
- Professional written and spoken communication skills with internal and external customers, colleagues and supervisors. Experienced user of the MS-Office package, Adobe Acrobat and database systems
- Finnish and English language fluency, written and spoken – fluency in an additional Nordic language is considered an advantage
- Opportunity to conquer exciting and varied challenges alongside an experienced and talented team in a dynamic company
- External business interaction with clients and internal collaboration within the PharmaLex organization
- Broad range of initiatives for personal development and professional training
- A friendly, supportive and openminded work environment in a global organization
If you are interested in joining our PharmaLex team taking over this challenging job opportunity in our future-oriented company, please, email your application documents as soon as possible to Joska.email@example.com. If you have any questions about the opportunity, feel free to reach out by email or call us at +45 44 12 89 87.