Jessica Hides

Regulatory Affairs Supervisor @Doncaster Pharma

Doncaster, GB

Manage day-today operations within the regulatory department, delegating workload and ensuring tasks are completed in compliance with internal SOP’s and GDP guidelines.• Train and support regulatory officers through one-to-one meetings and performance feedback.• Act as a key point of contact for collaboration with internal departments such as QA, Commercial and Planning to ensure timely resolution of regulatory queries, advising on regulatory updates and licence changes and compliance through the whole portfolio.• Liaise with national competent authorities and regulatory bodies,(including MHRA, HPRA and EMA), to clarify regulatory requirements, facilitate timely approvals and resolve queries. • Prepare and submit regulatory applications, variations and renewals.• Ensure compliance with Windsor framework agreement and Falsified Medicines Directive where applicable.• Support audits and inspections by providing documentation, maintaining accurate records and complying with data integrity.• Create and edit repacking artwork mock-ups for reboxes and alert cards using Adobe InDesign, ensuring compliance with regulatory and market-specific requirements.• Managing notifications to trademark owners in a timely manner, ensuring compliance with intellectual property requirements.

University of Lincoln

BSc, Events Management