Junior Regulatory Affairs Associate

at  Torbay Pharmaceuticals

About Torbay Pharmaceuticals
At TP, we have our own special kind of chemistry. Our heritage spans over 50 years with a track record of manufacturing essential medicines across the UK and beyond. With backing from an investment partner, we are now forging a new path in the private sector.
We are a growing and ambitious business and with this comes opportunities for our people. At TP, we are going places. A career with us means a career helping save lives. We bring skills of all levels and experiences together; not all of our people begin their working lives in pharma. Together we can make lives better.

• Provide documentation support to the Regulatory Affairs Team for preparing, formatting, regulatory filing and tracking of applications to our drug product licences
• Liaise with regulatory bodies and provide feedback to both the team and across TP
• eCTD publishing involving final compilation of regulatory documents as an electronic submission into Health Authorities Regulatory Bodies via national portals
• Support the general maintenance of the pharmacovigilance (PV) system (drug safety system) for TP Ltd products which ensures patient safety by monitoring and evaluating the clinical use of products.
• Responsible for maintaining document control of the large, technically complex product dossiers, to ensure an accurate electronic filing system
• Liaising across multi-functional TP teams and external consultants including the Qualified Person for Pharmacovigilance
• Manage the regulatory publishing for all licence applications and licence updates in line with agreed targets and timelines
• Perform monthly reconciliation of safety information from customers, distributors and licensing partners to ensure compliance against contractual agreements and legislative requirements
• Coordination of meetings (departmental and external) e.g. booking; producing agendas; meeting notes; action logs
• Responsible for collating and distributing regulatory and PV metrics to support team compliance
• Responsible for ensuring Quality Management System (QMS) documents & actions are completed in a timely fashion