Regulatory Affairs Associate, Labelling (Cambridge, UK) The Opportunity Cycle Pharmaceuticals is looking for an enthusiastic and confident team member to join our Regulatory Affairs Department as a Regulatory Affairs Associate, Labelling. Overview of the role The Regulatory Affairs Associate, Labelling will support day-to-day labelling activities and assist in regulatory submissions, focusing on the preparation and review of product labelling documents for various global markets. This position will work closely with internal and external stakeholders to ensure regulatory compliance, helping maintain and update labelling information across Cycle’s product portfolio. This role provides an opportunity to develop experience within regulatory affairs, particularly in labelling, across different therapeutic areas such as metabolic, immunology, and neurology. Job Interactions & Interface: This role interacts internally with key areas such as Quality, Product Development, Medical Affairs and Compliance, Finance, Marketing, Supply Chain, Regulatory CMC, Quality, Legal and Project Management. Externally, this position supports the line manager in interactions with CMOs, etc as requested. Our Company At Cycle, we believe that Every Single Patient Matters, this is at the heart of why we work, and we’d love for you to share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen. We are a pioneering pharmaceutical company, reimagining how drugs and services can benefit patients with rare disease to make their lives easier and improve their quality of life. Cycle, as a company, works closely with patient groups and healthcare professionals to understand the unmet needs of patients and their carers. By collaborating with academic communities and using the latest cutting-edge pharmaceutical technologies, we translate innovations into medicinal products that patients and caregiver’s desire. We deliver the required medicine with the minimum impact on daily routines and, just as importantly, provide individualized support services to patients, families, carers and the healthcare professionals community. Cycle has three core areas of pharmaceutical development and work across rare metabolic, immunological and neurological genetic conditions: improving drugs – optimizing an existing drug; repurposing drugs – creating a new indication for an existing drug; and generics – reinstating generic drugs, previously available in the market. These three areas of focus are underpinned by formulation technology – using new drug delivery technologies to improve the efficacy and effectiveness of drugs, allowing us to give patients greater freedom and choice. Job Title: Regulatory Affairs Associate, Labelling Cycle Company: Cycle Pharmaceuticals Ltd Position Summary: This is a permanent position within the Regulatory Affairs department, working in our Cambridge office. What you will be doing Key Responsibilities Labelling: Support labelling activities for all registered Cycle Products across UK, US and other global locations with support from the line manager and external parties. Support artwork preparation and review in collaboration with internal and external stakeholders. Assist in the maintenance of labelling data and documents in Cycle’s systems. Contribute to the preparation of regulatory dossiers from a labelling perspective. Support the on-going enhancement of the labelling processes and Standard Operating Procedures (SOPs). Assist in the preparation, review and approval of global labelling documents, including artwork files and print proofs to ensure content is accurate. Help maintain labelling data and documents in regulatory systems, ensuring up-to-date records for all registered products. Assist in the implementation of labelling changes, coordinating with cross-functional teams to ensure timely execution. Contribute to the maintenance of the Company Core Data Sheet with support from senior team members. Ensure proper documentation and tracking of labelling changes and approvals, maintaining accurate records for audits and regulatory submissions. Assist with promotional material submission to Health Authorities. Support regulatory submissions by contributing to labelling sections of dossiers and documents for submission to health authorities. General: Engage in cross-functional team meetings, providing regulatory support and updates on labelling activities. Stay updated on relevant labelling regulations and industry trends, applying new knowledge to labelling practices and sharing insights with the team. Assist in training internal stakeholders on labelling compliance and regulatory requirements when necessary. Qualifications & Skills: Technical Skills and Experience: A minimum of Bachelor´s degree in a life science related degree At least 1 year experience within Regulatory Affairs or artwork creation. Familiarity with global regulatory agencies such as the US-FDA and MHRA; additional experience with non-US regulators is a plus. Ability to interpret regulatory requirements and summarise scientific information accurately with support from senior team members. Personal Skills Strong written and verbal communication skills. High attention to detail and ability to maintain accuracy in regulatory documentation. A collaborative approach, with the ability to work effectively within a team environment and contribute to project goals. Strong time management and organisational skills, capable of managing multiple tasks and meeting deadlines. Self-motivated and proactive, with a desire to develop expertise in regulatory labelling. Problem-solving and critical thinking skills, with the ability to offer solutions in labelling tasks. What can we offer to you In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will enjoy all the benefits that brings: Competitive salary based on experience A collaborative high performing work environment Performance based bonus Opportunity to join a fast growing and ambitious business Company pension scheme 100% employer paid membership for Private Health Insurance Life and Critical Illness Insurance Corporate Gym membership Regular team building events and an agile working environment Applications Cycle Pharmaceuticals embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.