Compliance Office Specialist - Legal (Permanent)

Regulatory Affairs Associate, Labelling (Cambridge, UK) Cycle Pharmaceuticals is looking for an enthusiastic and confident team member to join our Regulatory Affairs Department as a Regulatory Affairs Associate, Labelling. 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. 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. 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. 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; Job Title: Regulatory Affairs Associate, Labelling Cycle Pharmaceuticals Ltd This is a permanent position within the Regulatory Affairs department, working in our Cambridge office. Assist in the maintenance of labelling data and documents in Cycle’s systems. Contribute to the preparation of regulatory dossiers from a labelling perspective. 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. Support regulatory submissions by contributing to labelling sections of dossiers and documents for submission to health authorities. Engage in cross-functional team meetings, providing regulatory support and updates on labelling activities. Assist in training internal stakeholders on labelling compliance and regulatory requirements when necessary. 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; Ability to interpret regulatory requirements and summarise scientific information accurately with support from senior team members. 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. Self-motivated and proactive, with a desire to develop expertise in regulatory labelling. Competitive salary based on experience ~ 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 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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.