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Search Results for Regulatory Affairs Manager
Job Title. Location Salary Actions

Quality Manager - NPI

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Manager - NPI
EU 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
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