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Search Results for Regulatory Affairs Clinical Research
Job Title. Location Salary Actions

Senior Manager Regulatory Affairs

Senior Manager Regulatory Affairs Our client, a global pharma company, are currently recruiting for a Senior Manager Regulatory Affairs to join their team on a permanent basis. Prior experience of people management is essential for this role. This role offers hybrid working. Responsibilities Recruit, develop, and retain a diverse and highly capable workforce Ensure robust individual training plans and timely completion of required training for direct reports Support and enable talent identification and career development that reflects an ...

Location: Cork,
Senior Manager Regulatory Affairs 		Cork Not Disclosed

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 Clinical Research Career Profile

Regulatory Affairs Clinical Research


Working in a CRO (Clinical Research Organisation) means working on large projects simultaneously. The regulatory filing for every stage of the clinical trial needs to be looked after for progress on the drug to be made. Below is an example Spec for a Senior role in a CRO:

Key Responsibilities

  • Liaise directly with regulatory bodies such as EMA & National Competent Authorities and you will maintain relations with key contacts
  • Work as part of the EMEA Regulatory team.
  • Evaluate data, review documentation and support/prepare documentation for medicinal products and medicals devices, as appropriate, for all stages of product development i.e. CTA through to life cycle maintenance
  • Maintain an accurate record of the time and direct costs associated with each project for which you are responsible and where appropriate produce status reports.
  • You will support the Regulatory Project Lead and dependent on the size of and nature of the project assigned, you may act as the Regulatory Project Lead and you will deal directly with the sponsor and Regulatory Agencies
  • Control all project related documentation either in paper or electronic form.

Skills / Experience

  • Must have 4-5 Yrs in a similar position.
  • Must have a science degree in a related field.
  • Knowledge of European guidelines and be able to review and evaluate CMC, Pre-Clinical and/or Clinical data in compliance with the relevant guidance.
  • Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner.