Job Details:

Regulatory affairs manager
My client, a family owned pharmaceutical company with a focus on innovative drugs in a wide range of therapeutic areas, mostly focused on paediatric indications, is seeking for a Regulatory Affairs Manager to join their growing team near Mannheim.
The role:
- Supporting of preparation groups in questions regarding quality, effectiveness and safety
- Preparing and implementing of national and international approval procedures
- Lifecycle Management of approved products
- Creating and maintaining of approval dossiers in eCTD format
- Cross-departmental cooperation within the framework of the approval of new CMOs
Requirements:
- 5+ years of experience in a regulatory affairs role, especially in support of approvals in the EU, DCP/ MRP
- Fluent German and English
- Relevant educational background
- Strong, hands on personality
The role is in a motivated, family-like team and has a high degree of independence. Among other benefits, it offers attractive compensation with profit sharing options.
If this sounds appealing to you, or you would like to find out more, apply here or get in touch with Michaela Plamenova via LinkedIn.
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