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Regulatory Affairs Associate
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Your new company
An established pharmaceutical organisation is seeking a Regulatory Affairs Associate to join its Regulatory Affairs team in London. Working within a collaborative international environment, you will support regulatory submissions, product lifecycle maintenance activities, and compliance across UK and EU markets.
Your new role
As a Regulatory Affairs Associate, you will support the preparation, review, and submission of regulatory documentation to Health Authorities. You will assist with new applications and post-approval maintenance activities, ensure regulatory databases and trackers are accurately maintained, and liaise with both internal and external stakeholders to support compliance and product lifecycle management.
Key responsibilities include:
- Supporting the preparation and submission of regulatory applications across the UK and EU.
- Reviewing changes to existing product licences and supporting regulatory strategies.
- Reviewing documentation intended for Health Authority submissions.
- Managing assigned regulatory activities in line with project timelines.
- Maintaining regulatory trackers and communicating approvals to relevant stakeholders.
- Supporting licence compliance activities and advising internal teams where required.
- Ensuring marketing authorisations remain compliant with relevant UK and European regulations.
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What you'll need to succeed
- BSc in Chemistry, Pharmacy, Life Sciences, or a related discipline.
- Minimum of 2 years' experience within the pharmaceutical industry.
- Understanding of UK and EU regulatory requirements for medicinal products.
- Experience preparing and reviewing regulatory submission documentation.
- Knowledge of electronic submissions, eQMS systems, and change control processes.
- Excellent written and verbal communication skills.
- Strong organisational and time management skills with the ability to manage multiple priorities.
- A collaborative and professional approach with a commitment to regulatory compliance.
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What you'll get in return
- Opportunity to develop your Regulatory Affairs career within a growing pharmaceutical business.
- Exposure to a broad range of regulatory activities across the UK and EU.
- Collaborative working environment with cross-functional stakeholder engagement.
- Competitive salary and benefits package.
- Hybrid working opportunities
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
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