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

Health Products Distribution Inspector

Health Products Distribution Inspector Our client, a Dublin based regulatory body are currently recruiting for a Health Products Distribution Inspector to join their team. The successful candidate will Report to the Health Products Distribution Inspections Co-ordinator. Responsibilities • Responsible for assessing the compliance of a wide range of national operators involved in certain activities of the pharmaceutical, cosmetic, chemical and medical device industry • Evaluate the compliance of sites inspected, with the requirements of national legislation, ...

Location: Dublin,
Health Products Distribution Inspector
Dublin Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Senior Regulatory Compliance Officer Dublin Not Disclosed
Senior Regulatory Compliance Officer Dublin Not Disclosed
Senior Regulatory Compliance Officer Dublin Not Disclosed
Senior Regulatory Compliance Officer 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