Smart4 Sciences
Regulatory Affairs Officer
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Regulatory Affairs Officer
Location: Tintagel Way, Walsall
About the job
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.
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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.
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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.
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.
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