Regulatory Officer

Regulatory Affairs Officer

Location: Tintagel Way, Walsall

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.

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.
• Pharmaceutical/admin variations.
• PIL variations.
• NL initial applications.

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.

• Registering products on AMF.
• Allocating barcodes via GS1 for products.
• Booking in samples.
• Sending coded leaflets and cartons to production.
• Maintaining departmental databases.

• Carrying out ad-hoc duties as required.
• Working additional hours when required to meet business needs.
• Assisting other departments as required.
• Maintaining a flexible approach and rotating responsibilities when needed.

• 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.

If you have pharmaceutical Regulatory Affairs experience and are looking for your next opportunity, we''d love to hear from you. Apply today with your CV to be considered.