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

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist – Post market Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Rep...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist
EU Not Disclosed

Associate / Sr Associate (Regulatory Labelling)

Associate / Sr Associate - Regulatory Labelling Our client is a global healthcare leader. Their employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. They are looking for people who are determined to make life better for people around the world. For more than 140 years, they have worked tirelessly to discover medicines that make life better. They are currently seeking a Labelling Associate / Senior Labeling...

Location: Cork,
Associate / Sr Associate (Regulatory Labelling)
Cork Not Disclosed

Senior Reg Affairs Specialist - Post Market

Job title: Senior Regulatory Affairs Specialist – Post market Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to t...

Location: Galway, Galway City,
Senior Reg Affairs Specialist - Post Market
Galway Not Disclosed

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist – Premarket Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Company: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities. Role: As a Senior Regulatory Affairs Specialist you will will pl...

Location: Clare, Connaught, Galway, Galway City, Limerick,
Senior Regulatory Affairs Specialist
EU Not Disclosed

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.