Description
My Dublin based client, who is one of the leading generics companies worldwide, is seeking to hire a Regulatory Compliance Officer to join their expanding team. This company maintains one of the industry's broadest and highest quality product portfolios The regulatory compliance team are responsible for managing the information flow between the various worldwide registration centres and with the relevant stakeholders within the company for marketed products, product transfers and product launches.The group is responsible for ensuring that the stakeholders have the necessary information to ensure that manufacture, testing and release of medicinal products is in accordance with the requirements of the marketing authorisations, and that product supplied to the company is also in accordance with these authorisations. The group is also responsible for being the mechanism for regulatory change within the company.
The Regulatory Compliance Officer:
- To review registration information and provision of this information to relevant departments, and ensure regulatory compliance for all products released by the company
- To review registration information supplied by various registration centres and provide the information as appropriate to the relevant departments
- To prepare, review and approve Manufacturing and Analytical records for their manufactured products and approval of External product documentation, in accordance with registered details.
- To coordinate the MRA Reduced Testing and Annex 16 Programmes.
- To support Product Transfer and Product Launch compliance activities
- To support change control and the registration variation process.
- To support continuous improvement projects for the Operational Excellence Programme.
- Involvement in site projects from a Regulatory Compliance perspective
- To maintain high standards of GMP at all times.
- To adhere to all company and legislative health, safety and environmental requirements.
- Any other duties assigned by the Regulatory Compliance Manager/QA Director.
Requirements for the regulatory compliance officer role:
- 3rd level qualification in science related discipline.
- Minimum 3 years experience within the pharmaceutical industry.
- Experience working in Regulatory
- Relevant experience in GMP/GLP environment.
There is an excellent salary plus benefits on offer. If you are interested in this position please contact me on .
To find out more about Real please visit www.realstaffing.com