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Search Results for Regulatory Affairs Manager
Job Title. | Location | Salary | Actions |
Regulatory Affairs DirectorRegulatory Affairs Director Our client a global healthcare company is currently seeking a Technical Device Regulatory Affairs Director to join their team. Director will be responsible for all aspects of Regulatory Affairs for their portfolio of devices Role/Responsibilities: Accountable to define device regulatory requirements and regulatory strategy to development teams to ensure readiness for medical device (MD) and combination product (CP) approvals. Critically review, approve, and lead strategy for global regulatory submissions for device compo...Location: Dublin, |
Dublin | Not Disclosed |
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
Microbiology PhD Pharma Sales Supply Chain Clinical Research Packaging Engineer Medical Device Sales and Marketing Allied Healthcare Diagnostics IT Chemistry Manufacturing Executive Quality Assurance Biopharmaceutical Engineering Connected Health Medical Affairs Validation Engineer Laboratory Scientist Academic Limerick Project Manager Dublin Cork Cork City Academic Scientist Product Development Engineer Pharmaceutical Biotechnology Sales and Marketing Quality Control Life Science Mayo Quality Engineering Scientific Supply Chain
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This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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