Our Client based here in Galway are looking to hire a Principal Regulatory Affairs Specialist.
This is a permanent role offering a generous salary and benefits package as well as hybrid working.
As the Principal Regulatory Affairs Specialist you will work on innovative strategies for regulatory approval, anticipate and respond to changing regulatory requirements, and provide strategic leadership to influence the global regulatory environment.
- Directs and influences the preparation of documentation to support high quality regulatory submission dossiers.
- Partners with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies for changes to existing products.
- Engages with regulatory agencies representing the company and ensuring the voice of the regulator is considered in developing regulatory strategies.
- Engages with global international regulatory partners to support regulatory strategy for changes to existing products.
- Leads regulatory filings to support submissions, license renewal and annual registrations.
- Support manufacturing strategy via a robust change control approach to ensure global approval and implementation of product and process changes.
- Mentors and coaches’ other employees within the department and provides leadership support to ensure strong talent development.
- Keeps abreast of regulatory procedures and changes. Supports industry advocacy activity to shape the future of evolving regulatory requirements. Develops internal procedures to ensure continuous compliance with all regulatory requirements. Influences clinical evidence strategy to support labeling content, marketing claims and regulatory compliance.
- Supports 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.
- We are looking for a qualified person to Level 8 Science or Engineering Degree/Masters. A Regulatory Affairs qualification is desirable, but not mandatory.
- Regulatory experience in Medical Devices and or Pharmaceuticals is required.
- You are a recognized expert, capable of managing large projects or processes.
- 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, at times acting as a team leader.
- You are a strong coach/mentor and can provide coaching/training to other employees within the RA Department.
- You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behavior.
- You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills.
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.
091 706 717