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 in Sweden is growing, and we are looking for a new Stockholm based team member.
Regulatory Affairs Manager
- 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) 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
- On occasion working in a client’s office may be necessary for certain short-term projects
- Proven experience in evaluation, preparation and compilation of quality documentations and/or experience in regulatory processes (registration procedures, renewals, variation procedures)
- University degree in pharmacy or other natural sciences
- 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
- Swedish and English language fluency, written and spoken
- 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 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, we are looking forward to receive your application documents as soon as possible.
Agencies only by prior agreement for the specific job opportunity.