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Regulatory Affairs Officer (RAO440)




Job Location
- Ireland -- Leinster -- County Westmeath -- County Westmeath -- Athlone

Job Type

09 June 2021

Regulatory Affairs Officer – Competitive Salary, 9 month Fixed Term Contract – Athlone, Ireland

The Role

Kent-Athlone Pharma Group, one of the leading suppliers of medicines and penicillin products across international markets, are seeking a Regulatory Affairs Officer.

The successful candidate will prepare and submit licence and variation applications, ensuring prompt responses to all requests for information from the various regulatory authorities.

The key responsibilities of a Regulatory Affairs Officer include, but are not limited to:

  • Ensuring licence maintenance and compliance in accordance with relevant guidelines and directives, including support and input on Product Quality Reviews.
  • Ensure all operations are fully compliant with licence details and updated in accordance with relevant guidelines and directives.
  • Ensure compliance files/eCTD files are maintained for all licensed penicillin products manufactured and/or released at Athlone.
  • Work to the relevant change control system.
  • Maintain regulatory trackers.

The Company

The Kent-Athlone Pharma Group specialises in the reliable and consistent supply of a wide range of generic and specialty pharmaceuticals and is a leader in anti-infective products manufactured in its modern facility in Athlone, Ireland.

The Kent-Athlone Pharma Group was created in September 2019 following Duke Street Capital’s acquisition of Kent Pharmaceuticals, a leading international supplier of medicines, and Athlone Laboratories, a key supplier of penicillin products to global markets.

The Person

The key skills and qualities of a Regulatory Affairs Officer at Kent-Athlone Pharma Group are:

  • Third Level qualification in a scientific discipline
  • Experience in the pharmaceutical industry would be an advantage.
  • A well-organised approach, underpinned by the ability to communicate effectively with
  • people at all levels, both verbally and in writing.
  • Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.

If you are keen on joining this exciting, forward thinking company and taking the next step in your career, then please click the apply now button to find out more.

Contact information

Balwinder Kang