Our Client is the number 1 service provider of Medical Devices, Medicines and Services to the healthcare sector.
Principal Duties and Responsibilities:
- Ensure that all new licence and variation applications are planned, tracked and obtained in a timely manner in accordance with various EU submission procedures.
- Preparation and submission of licence 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 licence 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 .
- Review of relevant reports to ensure compliance with licence 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 licence 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 licence and variation approvals.
- Work to department KPIs.
Qualifications & experience:
- 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.
The role demands 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.