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Regulatory Affairs Specialist
2 months ago
ProPharma Group is seeking a highly skilled Regulatory Affairs Specialist to join our team in Stockholm or Lund. As a Senior Regulatory Consultant, you will work on projects from various Pharmaceutical companies, dealing with challenging tasks that require result orientation and excellent interpersonal skills.
The role involves working with Regulatory Affairs, primarily on a local level, with focus on the Nordic countries. Key responsibilities include:
- Working with new registrations, variations, and MAH-transfer applications
- Regular contact with health authorities
- Regulatory intelligence
- Local regulatory advice
- Launch preparations
- Strategic and operational regulatory support to clients and colleagues
Qualifications:
- Understanding of registration procedures and requirements
- Ability to work to deadlines and solve issues in a pragmatic and proactive way
- Excellent communication skills in Swedish and English
- 5+ years of experience in Regulatory Affairs, primarily focused on Nordic regulations
- MSc in Pharmacy or equivalent
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