Regulatory Affairs Manager
I am currently partnering a full-service Swedish CRO who is expanding their regulatory group and looking for a Regulatory Affairs Manager to join them on a permanent basis. The correct candidate can have the option to work in the office from Stockholm, Uppsala or Malmo.
- Regulatory submissions for approvals of new products, line-extensions; managing the preparation, content and format of the dossier, responding to authority questions for medicinal products
- Review and approval of packaging materials
- Compliance tasks; review of promotional materials according to applicable legislations and guidelines
- Driving submissions of variations and renewals
- Preparation and maintenance of product information
- Report progress of projects and other services according to agreement with project manager, line manager and customer
- Complete projects/services according to the agreement with project manager, line manager and customer
- Pharmacist background
- Experience within Regulatory Affairs
- Fluent in Swedish and English (written and oral)
- Knowledge about Pharmaceuticals and Biotech Products
This position is office based in either Stockholm, Malmo or Uppsala and my client can be flexible with notice periods. For more details, please apply.