Reporting to the Regulatory Affairs Manager, you will play a key role in preparing and maintaining regulatory submissions, ensuring products remain compliant with regulatory requirements.

• Key ResponsibilitiesPreparations of:PLPI/initial applications.
• RFI responses.
• pharmaceutical/admin variations.
• PIL variations.
• Renewals.
• Trademark Queries.
• NL initial applications (including Grey/Finished PI).
• NL internal updates.
• NL TM/Trading standards/UK RP letters.
• PLPI Company Functions List variations.
• Proofreading/final checks of:PLPI/initial applications.
• RFI responses.

• About YouYou will ideally have:Previous Regulatory Affairs experience within the pharmaceutical industry.
• Knowledge of UK pharmaceutical regulations and regulatory submissions.
• Experience preparing variations, renewals and regulatory applications.
• Familiarity with Marketing Authorisations, PILs and SmPC documentation.
• Excellent attention to detail with strong proofreading skills.
• Strong organisational and administrative abilities.
• Excellent written and verbal communication skills.
• The ability to manage multiple projects and deadlines effectively.
• Working knowledge of GMP and GDP.
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