Principal Regulatory Affairs Specialist

Sigmar Recruitment

Galway

Principal Regulatory Affairs Specialist. Principal Regulatory Affairs Specialists are directly involved in regulatory activities supporting the global commercialization and sustaining of products on the market in compliance with all regulatory requirements.   What you will do: Directs and influences the preparation of documentation to support high quality regulatory submission dossiers. Engages with global international regulatory partners to support regulatory strategy for new products/therapies and changes to existing products. Partners with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies. Engages with global regulatory agencies representing the company and ensuring the voice of the regulator is considered in developing global regulatory strategies. Support manufacturing strategy via a robust change control approach to ensure global approval and implementation of product and process changes. 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. Develops strategies for earliest possible global approvals of regulatory filings. 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.   What you will need: We are looking for a qualified person to Level 8 Bachelor’s Degree/Masters or equivalent in Science, Engineering or related discipline. Regulatory experience in Medical Devices and or Pharmaceuticals is desirable, however, candidates with a minimum of 6 year’s relevant experience will also be considered. 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 are a good communicator and fluent in English, both in writing and speaking with strong organizational skills.   What you will receive: Competitive Salary & Comprehensive Benefits Package, Training & Development.   To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie   All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent.  .

1255 days ago