Job Description
An experienced Regulatory Affairs professional is sought to contribute to a growing team in a company with a diverse product portfolio offering great exposure opportunities.
A Regulatory Specialist is needed to join an expanding team in a pharmaceutical company based in Cork. This permanent role offers a hybrid work option of three days remote work. The successful candidate will provide regulatory specialist advice for new products and support the full lifecycle maintenance activities for the portfolio in Ireland.
The ideal candidate has a background in Science or Pharmacy with a minimum of two years' experience in a regulatory or pharmacovigilance role working in the Pharmaceutical or healthcare industry. They will be an excellent communicator and team player. Experience in branded treatments, medical devices, animal health, or cosmetics for oncology would be desirable.
Key Responsibilities:
* Ensure the Irish affiliate remains compliant and inspection-ready.
* Support audit and communication with regulatory and notified bodies.
* Maintain the portfolio of products marketed in Ireland, ensuring Marketing authorisation are updated, including submission, variations, and renewals.
* Manage individual portfolios and create/maintain SOPs and regulatory documents to ensure compliance.
* Engage in continuous improvement and advocate for the company internally and externally.
This role requires a skilled Regulatory Affairs professional who can contribute to the growth and success of our company in Ireland.