Regulatory Affairs Officer

An exciting opportunity has arisen for a Regulatory Affairs Officer to join a well-established pharmaceutical company. This role is ideal for someone with experience in pharmaceutical regulatory affairs who enjoys working in a fast-paced, quality-driven environment and is looking to develop their career within a supportive regulatory team.

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 Responsibilities

Preparations 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 You

You 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.

What’s on Offer

• Opportunity to join a reputable pharmaceutical organisation.
• Supportive and collaborative working environment.
• Career development and ongoing training.
• Competitive salary and benefits package.
• The opportunity to make a real impact within a growing Regulatory Affairs function.

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