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

Director Regulatory Affairs

Director Regulatory Affairs Our client, a growing biotech organisation are currently recruiting for a Director of Regulatory Affairs to join their organisation on a permanent basis. As Director of Regulatory Affairs will be responsible for the coordination and the day-to-day support of the regulatory affairs strategy and operational activities of the organisation. You will provide support to both CMC, non-clinical, and clinical development. Responsibilities Coordinate input from external regulatory affairs consultants, identify and close knowledge gaps Provide regulatory...

Location: Dublin, Republic of Ireland,
Director Regulatory Affairs 		Dublin Not Disclosed

CMC Regulatory Specialist

CMC Regulatory Specialist Our client, a global pharma company are currently recruiting for a CMC Regulatory Specialist to join their team on a permanent basis.As CMC Regulatory Specialist you will support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance. You will closely with regulatory product representatives providing guidance to them regarding the regulatory documentation, reporting requirements and registration processes in global markets. ...

Location: Cork,
CMC Regulatory Specialist 		Cork Not Disclosed

CMC Regulatory Associate

CMC Regulatory Associate Our client, a global pharma company are currently recruiting for a CMC Regulatory Associate to join their team on a permanent basis.As CMC Regulatory Associateyou will lead and partner with Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in the various aspects of global marketing authorization submission management processes. You will build and manage submission content, provide guidance on structure and content placement within Common Technical Document (CTD) registration submissions, and to provide assistance with submission rel...

Location: Cork,
CMC Regulatory Associate 		Cork Not Disclosed

CMC-Development Regulatory Associate

CMC – Development Regulatory Associate Our client, a global pharma company are currently recruiting for a CMC Development Regulatory Associate to join their team on a permanent basis.As CMC Development Regulatory Associate you will create and manage submission documents and provide guidance on structure and content placement. You will work within regulations to expedite the registration and lifecycle maintenance of products, to ensure delivery of safe and effective products to patients.The scope of work includes global regulatory requirement assessment and understanding stra...

Location: Cork,
CMC-Development Regulatory Associate 		Cork Not Disclosed

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
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Senior Regulatory Affairs Galway Not Disclosed
Senior Regulatory Affairs Specialist Westmeath Not Disclosed
Regulatory Affairs Associate Dublin South Not Disclosed
Regulatory Affairs Associate Dublin South Not Disclosed
Senior Quality and Regulatory Manager 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.