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

Clinical Regulatory Associate

Clinical Regulatory Associate Our client, a global pharma company are currently recruiting for a Clinical Regulatory Associate to join their team on a permane

Location: Cork,
Clinical Regulatory Associate 		Cork Not Disclosed

Clinical Publisher Associate

Clinical Publisher Associate Our client, a global pharma company are currently recruiting for a Clinical Publisher Associate to join their team on a permanent basis. As Clinical Publisher you will create and maintain complex strategic and compliance submissions through collaboration, document management, and internal database maintenance. You will collaborate with Regulatory Associates, Regulatory Scientists, cross-functional contributing/authoring areas, and affiliates to align on submission specific strategies and to ensure adherence to eCTD regulations and guide...

Location: Cork,
Clinical Publisher Associate 		Cork Not Disclosed

Director, Regulatory Affairs (Pediatrics/Infectious Diseases)

Our client is a global Biopharma who are establishing a new Peadiatric Centre of Excellence in Dublin, Ireland. This is an exciting opportunity to lead a Pediatrics Regulatory Affairs function in the area of Infectious Diseases where you will provide global regulatory strategic and technical leadership of regulatory activities for pediatric product development. Role/Responsibilities: Responsible for providing strategic regulatory guidance on the development of global pediatric submissions, including those required in the US and EU. Responsible for leading all pediatric-...

Location: Dublin,
Director, Regulatory Affairs (Pediatrics/Infectious Diseases) 		Dublin Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Quality and Regulatory Affairs Manager Dublin Not Disclosed
Senior Regulatory Affairs Specialist Dublin Not Disclosed
Quality and Regulatory Affairs Manager Dublin Not Disclosed
Regulatory Associate CMC (LO A008365) Cork Not Disclosed
Principal Regulatory Lead Galway 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.