About the role
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.
Pharmaceutical/admin variations.
PIL variations.
NL initial applications.
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.
Ongoing Tasks
Registering products on AMF.
Allocating barcodes via GS1 for products.
Booking in samples.
Sending coded leaflets and cartons to production.
Maintaining departmental databases.
Other Duties
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.
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
About this listing
Screened by Joboru
This role passed our automated spam and quality filters and was active in our feed when last checked. Joboru is an aggregator — here is how we screen listings. If anything looks off, tell us.
Similar jobs you may like
Home Care Worker
4 days agoGoldsmithpersonnel Ltd
Veterinary Surgeon
4 days agoHireful
Head Veterinary Surgeon
4 days agoHireful
Trainee Registered Manager
4 days agoSafer Hand Solutions Ltd
Optometrist Opportunity Southampton / Market Leading Package / £65,000!
4 days agoVivid Optical
Occupational Therapist - Clinical Advisor
4 days agoSJB Medical
Deputy Manager (Learning Disabilities)
4 days agoSouthdown
Care Worker
4 days agoPremier Care (Midlands)
Children's Advanced Social Worker Family Safeguarding
4 days agoSurrey County Council