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Principal Regulatory Affairs Specialist

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 23108

Our client a major multinational here in Galway are looking to hire a Principal Regulatory Affairs Specialist on an initial 12 month contract.


Responsibilities:

  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

  • Leads or compiles all materials required in submissions, license renewal and annual registrations.

  • Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking / control systems.

  • Keeps abreast of regulatory procedures and changes.

  • May direct interaction with regulatory agencies on defined matters.

  • Recommends strategies for earliest possible approvals of clinical trials applications.

Requirements:

  • Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

  • May have broad knowledge of project management.

  • Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717