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Search Results for Regulatory Affairs Consultant
Job Title. Location Salary Actions

Senior Reguatory Specialist

Role: Senior Regulatory Specialist Location: Dangan, Galway Benefits: Competitive salary, Bonus up to 10%, Healthcare contribution, stock options and a flexible office and home working environment. Company: Founded in 2018 My client are a growing business with an exciting technology developing innovative catheter-based technology to remove clots from the brain following Acute Ischemic Stroke. The technology is designed to provide superior clinical outcomes in shorter procedural times, resulting in safe, cost-effective therapy. ...

Location: Galway City,
Senior Reguatory Specialist 		Galway City Not Disclosed
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Regulatory Affairs Consultant Career Profile

Regulatory Affairs Consultant


Whether it's working in a solo-operation, or in a Regulatory Consultancy, working as a consultant can give flexibility and great challenges to a Regulatory expert with a number of years in industry.

Key Responsibilities

  • Timely preparation and submission variations and renewal applications for National and MRP procedures to the IMB, MHRA and other regulatory authorities.
  • Provide responses to the competent authorities on deficiencies where they arise.
  • Review and update of summary of product characteristics and patient information leaflets as required.
  • Provide guidance and support regarding regulatory requirements as requested by clients.
  • Preparation of clinical trial submissions to various regulatory authorities.
  • Quality Control review of submission documentation prior to relevant competent authorities.
  • Perform internal audits & self-inspections to ISO 9000:2008 standard.
  • Participation in business development/marketing activities.

Skills / Experience

  • Degree minimum in a relevant area.
  • Significant experience in Regulatory setting (CRO / Medical Device / Pharma / Biotech).
  • Team player and client-focussed.