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.

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.

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