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Do you want to contribute to a safer market while gaining an authentic international experience as a consultant? Obelis is currently looking for a RA Expert Consultant specialized in food supplements! As a Food Supplements Expert Consultant, you will play a key role in supporting the Regulatory Affairs Department (RA) by providing senior regulatory expertise, overseeing complex projects, and contributing to the team's performance, operational efficiency, and achievement of departmental KPIs. • 1.Lead complex regulatory projects and provide expert regulatory guidance with a focus on food supplements compliance., • 2. Review and validate complex documentation and authority interactions., • 3. Drive technical excellence and departmental expertise., • 4. Act as a trusted advisor for strategic clients., • 5. Coach colleagues and support managers in coordination activities., • 6. Participate in Obelis events (in and outside UK), • 7. Support safe market access and work in an international consulting environment. The successful candidate will support clients on regulatory matters across the UK, EU, and US, with a primary focus on food supplements and is expected to become the designated Food Supplement PRRC, supporting appropriate regulatory oversight and accountability for food supplement compliance activities., • 8. Deliver professional, responsive, and high-quality service to external and internal clients., • 9. Act as, or work towards becoming, the designated Food Supplement PRRC, ensuring appropriate oversight of food supplement regulatory compliance activities in line with internal procedures and applicable requirements., • 10. Provide regulatory support covering UK, EU, and US product requirements, with particular emphasis on food supplements and related product categories., • 11. Perform borderline assessments to support appropriate product classification, including food supplement versus medicine, medical device, cosmetic, or other regulated product categories., • 12. Assess product composition, ingredients, claims (e.g. nutrition and health claims, including permitted claims, on-hold botanical claims, disease-risk reduction claims, and the avoidance of prohibited medicinal claims), labelling, and supporting documentation for regulatory compliance., • Applicants must hold a valid UK work permit., • Bachelor's/Master's degree in Food Science, Nutrition, Pharmacy, Chemistry, Toxicology, Biology or a related scientific discipline., • 3+ years of relevant experience in the food supplement consultancy sector., • Fluency in English (written and oral). Knowledge of additional languages is a plus., • Strong knowledge of regulatory applications and documentation review, • Solid understanding of regulatory environments and their impact on clients., • Analytical mindset with the ability to translate issues into practical improvements., • Ability to work cross-functionally across teams and stakeholders. At Obelis, we believe in continuous learning and professional growth. In this role, you will further develop your expertise in: • Regulatory strategy and expert advisory, • Project and stakeholder management, • Client advisory and relationship management, • Regulatory risk assessment and decision-making, • Location: Oxford, • Full-time position Obelis s.a is a quality-driven, service-oriented company, with over 30 years of experience in EU Regulations. Providing consultancies on medical devices, cosmetics, and other consumer goods, we believe in making manufacturers better through compliance and making safe products available on the market. #J-18808-Ljbffr

Oxford, UK Clinical Development The Clinical Project Manager (CPM) will be responsible for overall management and oversight of contracted clinical studies and/or programs, including (but not limited to) development of project documentation, training project staff, monitoring study progress to assess protocol adherence, administration and oversight of study budgets, management of third-party vendors for clinical services and/or contract CRAs, as applicable, management of project timelines, and development of project deliverables. They will work to ensure that all aspects of the conduct of the study and/or program are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. The CPM will be asked to participate in the company’s process improvement initiatives. Additionally, they could mentor study support staff (e.g. Clinical Trial Managers, Clinical Trial Associates) and may have direct reports (e.g. Clinical Trial Managers) across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality. • Responsible for the successful execution and oversight of assigned programs ensuring the deliverables are met with quality, timelines and budget, • Provide oversight and accountability of all third-party vendors assigned to a program, • Support RFP processes from proposal development through to vendor selection and contract negotiation, • Review, negotiate and approve any required change orders, • Management of the overall study budget, ensuring the budget stays within forecast and the approved budget, • Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures. Ensuring knowledge is kept up to date by reading SOP’s and maintaining awareness of GCP guidelines, • Ensure program meets all GCP/ICH Guidelines and is Inspection Ready, • Contribute to authorship of company protocol and amendment development as required, • Review and approve CRFs, IRTs and other relevant specifications from a clinical perspective, ensuring the successful support of data collection, • Routinely review study data and progress of EDC entry; working with data management and clinical sites to resolve data discrepancies. This includes reviewing primary and secondary efficacy and safety endpoints for inconsistency, irregularities, and/or signals, • Input into regulatory documents such as IB and DSUR, • Provide expert and collegiate support to other members of the drug development team to ensure full success of the company’s portfolio and regulatory milestones, • Identify and communicate study issues that will impact budget, resources and timelines, • Assist in SOP and working instruction development, review and approval within the company, • Manage supportive Clinical Operations function(s) (e.g., Clinical Trial Managers), by providing oversight and guidance of their task execution as required to ensure regulatory compliance of protocol activities, if appropriate, • Accountable for ensuring all study deliverables and milestones are met with quality and within timelines, • Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets, • Provide support/escalation point for direct reports as needed Essential Qualifications: • BA / BS. or higher in science related field (biological science, pharmacy or other health related discipline), • At least 4 years relevant experience in a biotechnology/pharmaceutical industry and/or clinical research organization, including majority of time in clinical study/project management., • Experience must include global/international studies or programs., • Experience in oncology is highly desired., • Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint) and ability to develop proficiency in relevant Immunocore IRT and EDC systems and programs, • Experience with Vendor oversight, • Fully understand and apply the principles of GCP, ICH, GDP and relevant CFRs is required, • Create and maintain healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required, • Ability to communicate and coordinate activities with the internal team, clinical sites and vendors, • Proactively identify project challenges/risks and appropriate corrective actions to the internal study teams and work with internal team, clinical sites and vendors on resolutions with minimal supervision, • Ability to work independently, • Experience presenting high level presentations, both orally and in writing using organizational skills to complement this, • Ensure an enthusiastic and open attitude towards continuous professional development Preferred Qualifications: • Proven ability to manage multiple protocols, • Familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus, • Experience with all aspects of the conduct of a clinical study including start-up through close out, • Knowledge of and experience with immunotherapies and/or Oncology therapeutic discipline Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions. Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases. At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits. Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law. #J-18808-Ljbffr

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