Senior Regulatory Affairs Specialist
Galway - Hybrid
Permanent
Senior Regulatory Affairs Specialist - Galway
Role Overview
Key Skills & Experience
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.