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| Job Title | Location | Salary | |
| Senior Regulatory Affairs Specialist | EU | Not Disclosed |
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| Quality Manager - NPI | EU | Not Disclosed |
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| Quality Manager - NPI | EU | Not Disclosed |
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Regulatory Affairs Manager Career Profile
Regulatory Affairs Manager
This role is normally suited to someone with a minimum of 5 years in a Regulatory setting, ideally more. Management, departmental budgeting, training are some of the keys tasks involved on the non-technical side of the role.
Key Responsibilities
- Coordinating, compiling and submitting Marketing Authorisation variations for existing approvals
- Composing and reviewing Pre-IND information packages and NDA packages for registration of prescription products in the US through the FDA
- Liaise with partner companies as the primary Regulatory Affairs contact for the company to achieve product registration in all new worldwide regions within projected timeframes
- Regulatory Affairs European project team leader for all new projects
- Interpreting EU and US regulatory guidelines and procedures and ensuring the regulatory compliance of the company in all new regions Establish and analyse department budget
- Identify and recommend areas for cost savings from and Regulatory and compliance perspective
- Provide Regulatory advice and feedback for all internal company departments and external partners
- Maintain and apply a high level of awareness and understanding of the impact of existing and future planned regulations