Regulatory Specialist

Description:

Full Job Description

This is a permanent role with hybrid option of working 3 days remotely. You will provide regulatory specialist advice for new products and support the full lifecycle maintenance activities for the portfolio in Ireland.

The successful candidate will have a background in Science or Pharmacy with minimum 2 years' experience in a regulatory or pharmacovigilance role working in the Pharmaceutical or healthcare industry. You will be an excellent communicator and team player. Experience in branded treatments, medical devices, animal health or cosmetics for oncology would be desirable.

Responsibilities:

• Ensure the Irish affiliate remains compliance and inspection ready.
• Support audit and communications with regulatory and notified bodies.
• Ensure all activities required for the launch of new products in Ireland including applications and maintenance of full product list.
• Maintain the portfolio of products marketed in Ireland, ensuring Marketing authorisation are updated including submission, variations, and renewals.
• Manage individual portfolios.
• Creation and maintenance of SOPs and regulatory documents to ensure compliance.
• Engage in continuous improvements.
• Advocate for the company internally and externally.