Regulatory Affairs Associate

About the Role

We’re looking for an enthusiastic Regulatory Affairs Associate to join our team and support the maintenance of our existing marketing authorisations. This is an excellent opportunity for an entry‑level regulatory professional (or a recent graduate with an interest in regulatory affairs) to gain hands‑on experience within a highly respected pharmaceutical organisation.

In this role, you will carry out regulatory activities with close support and guidance, helping ensure our products remain compliant with UK and EU requirements.

What We’re Looking For

• Confident and professional entry‑level individuals with an interest in regulatory affairs.
• Ability to apply foundational knowledge and begin developing understanding of UK and EU variation requirements.
• Minimal CMC knowledge needed – willingness to learn is key.
• Strong initiative, attention to detail, and planning skills.
• Good written and verbal communication abilities.
• Proficiency in Microsoft Office.
• Bachelor’s degree in a relevant scientific discipline.
• 0–2 years’ experience – new graduates welcome!

Key Responsibilities

• Execute variations for existing marketing authorisations in line with regulatory requirements and local laws (with supervision).
• Prepare and compile responses to authority questions within agreed timelines.
• Identify the correct documentation requirements for variation submissions.
• Review internal documentation to ensure compliance with marketing authorisations, escalating issues to your line manager as needed.
• Develop product information text in accordance with SOPs and relevant guidelines.
• Maintain regulatory systems and ensure timely communication to internal and external stakeholders in line with KPIs.
• Support departmental and business needs through other reasonable duties as required.
• Contribute to an effective Quality Management System and support the achievement of Quality Objectives.

Benefits

• Healthcare Cash Plan or Private Medical Cover – Personal cover to support your health and wellbeing.
• 3% Employee / 5% Company Pension Contribution – Helping you plan for the future.
• 26 Days Annual Leave + Bank Holidays
• Flexible Working – Including hybrid and flexible working hours available.
• …