Regulatory Manager

Regulatory Manager / Senior Regulatory Manager (Clinical Trials) Precision for Medicine is not your typical CRO. We bring new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing therapies to patients. Our focus is oncology and rare disease, and we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We are recruiting a Regulatory Manager / Senior Regulatory Manager to join our team. Candidates may be based in the UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland. Key Responsibilities Provide regulatory guidance throughout the clinical development lifecycle. Compile, coordinate and review applications to regulatory authorities (CTA/IND, annual reports, routine amendments, scientific advice, orphan designations, paediatric planning, marketing applications). Develop and/or review documents intended for submission to regulatory authorities and/or ethics committees to assure compliance with regulatory standards. Represent Global Regulatory Affairs at project team meetings with external and internal customers. Lead projects for the region or globally when necessary. Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs. Maintain project plans, trackers and regulatory intelligence tools, and keep Regulatory Leadership updated. Assist in developing Regulatory Affairs Specialists and other operational staff. Provide input into regulatory strategy and timeline development for new study opportunities; assist in establishing company standards to ensure the highest quality of submitted information. Participate in maintaining and executing corporate quality initiatives across business units within clinical solutions. Remain current with laws, regulations and guidelines governing drug development and approval. Provide ICH GCP guidance, advice and training to internal and external clients. Represent Global Regulatory Affairs at business development meetings. Minimum Qualifications Bachelor’s degree or equivalent experience, ideally in a scientific or healthcare discipline. 5 years regulatory experience for Manager level or 7 years for Senior Manager level. Computer literacy (MS Office/Office 365). Fluent in English. Preferred Qualifications > Graduate or postgraduate degree. Basic understanding of financial management. Additional Requirements Regulatory affairs experience working for a Clinical Research Organisation, including experience leading clinical submissions. Informed knowledge of all aspects of the drug development process, including regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US). Ability to understand clinical and pre‑clinical study results to inform regulatory positions and strategy. Knowledge of clinical trials methodology, protocols and indications being studied. Knowledge of relevant regulations and guidance supporting pharmaceutical development. Availability for domestic and international travel, including overnight stays. Core Competencies Strong interpersonal and team collaboration skills. Professionalism and punctuality, with dedication to service culture. Ability to manage multiple tasks in a fast‑moving environment with good record‑keeping. High self‑motivation and independent planning; also works well in a team. Ability to motivate others to meet timelines and project goals. Flexible attitude toward work assignments and continuous learning. Resolves project‑related problems and prioritises workload to meet deadlines with minimal management support. Focuses on continuous improvement and process efficiency. Collects data of consistently high standard. Effective communication in English, both verbally and in writing. Ability to conduct formal presentations to diverse audiences. We invite you to learn more about our growing organization serving clients researching ground‑breaking cancer therapies. We strive to ensure employees feel valued daily and your ideas will be nurtured to impact positive change in the company. Any data provided as part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. Contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com for reasonable accommodations for applicants with disabilities. #J-18808-Ljbffr