Regulatory Affairs Associate

For over 50 years, Rosemont Pharmaceuticals has been a trusted name in the development and manufacture of oral liquid medicines. With a portfolio of over 130 products - including 70 licensed medicines - we’re proud to support healthcare professionals and patients, especially those with swallowing difficulties. Our purpose is clear: to improve patient outcomes through innovation in liquid formulations. We’re highly respected across the pharmaceutical industry and have played a key role in establishing best practices for dysphagia care. Our mission is to create a globally connected, people-focused organisation where every individual is empowered to thrive and achieve their best. If you’re passionate about making a meaningful impact to patients across the world and want to be part of a company with a strong heritage and ambitious vision, we’d love to hear from you.

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

• Annual Bonus – Recognising your contribution to Rosemont.
• 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.
• Free On-Site Parking – Convenient access to our Leeds facility.
• Rosemont Rewards Platform – Discounts, free perks, and wellbeing tools for all employees.

We are committed to fostering an environment of enablement where our people can grow, develop their talents, and pursue meaningful career paths. By placing patients and customers at the heart of everything we do, we drive high performance through accountability, consistency, and a strong governance structure. We champion inclusion, community, and a rewarding employee experience - creating a culture that supports development, celebrates achievement, and empowers individuals to thrive.