Description
This company has grown significantly in the last few years and offers excellent progression opportunities.Principal Duties and Responsibilities of the Senior Regulatory Affairs Officer:
- Ensure that all new license and variation applications are planned, tracked and obtained in a timely manner in accordance with various EU submission procedures.
- Preparation and submission of license and variations to the HPRA, MHRA and other Regulatory Authorities as required.
- Liaise directly with the regulatory authorities in order to ensure timely approvals and speedy resolution of any issues.
- Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives.
- Ensure up to date files are maintained for all licensed products manufactured and/or released at the company's site.
- Review of relevant reports to ensure compliance with license details and relevant guidelines and directives.
- Review and approval of all new and revised master batch documentation, QC specifications and packaging work orders in line with license details and relevant standard operating procedures.
- Identification, compilation and approval of Regulatory SOP's.
- Assist in the training of new artwork and regulatory personnel.
- Set timelines for all license and variation approvals.
- Work to department KPIs.
- The Senior Regulatory Affairs Officer will need to have:
- Third Level qualification a scientific discipline
- Regulatory experience in a pharmaceutical industry of 3-5 years.
- EU submission experience will be an advantage, but not essential.
This is a full time, permanent role. An excellent salary of €35,000 - €45,000 + benefits (including 10% bonus) dependent on experience is on offer. For immediate consideration please reply with an updated CV or call Michael Bustamante on .