Senior Regulatory Affairs Specialist
​Galway - Hybrid

Permanent
Senior Regulatory Affairs Specialist - Galway

Role Overview
  • Directs or performs coordination and preparation of document packages for regulatory submissions.
  • Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products.
  • Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Supports change control activities to support global approval and implementation of product and process changes
  • Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
  • Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
  • May direct interaction with regulatory agencies on defined matters.
  • Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
  • Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.

Key Skills & Experience
  • We are looking for a person qualified to Level 8 Science or Engineering Bachelor’s Degree/Masters with a minimum of 4 years of relevant experience. A Regulatory Affairs qualification is desirable, but not mandatory.   
  • Regulatory experience in Medical Devices and or Pharmaceuticals is required.
  • You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
  • You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
  • You collaborate with others and create alignment with team members.​