[All remote jobs](https://jobicy.com/jobs.md)[![Precision Medicine Group logo](https://jobicy.com/data/server-nyc0409/galaxy/mercury/2025/06/f1277044-221.jpg)](https://jobicy.com/company/precision-medicine-group.md)[Precision Medicine Group](https://jobicy.com/company/precision-medicine-group.md) # Regulatory and Start Up Specialist AI Summary This remote UK role supports clinical-trial regulatory submissions and site start-up activities within a clinical research organization. The specialist prepares and maintains submissions to Competent Authorities and Ethics Committees, supports site activation, and manages essential regulatory documentation. Responsibilities also include tracking critical-path milestones, coordinating translations, maintaining inspection readiness, and collaborating with clinical operations, project management, feasibility, and site contracts teams. Candidates need life-sciences knowledge, at least two years of relevant experience, strong organization, and familiarity with UK regulatory and site-contract processes.[Apply for this job](#job-application)[View company](https://jobicy.com/company/precision-medicine-group.md)ShareRemote from[UK](https://jobicy.com/job-region/uk.md)SalaryUndisclosedDepartment[Healthcare & Medical](https://jobicy.com/categories/healthcare.md)EmploymentFull TimeExperienceSeniorPublished11 Nov 2026Apply before11 Dec 2026Listing views30Application actions3Application toolkit ## Make your next move. Prepare your resume, explore your fit, and draft a cover letter for this opportunity. Opportunity details ## About this role. Precision for Medicine is a global Clinical Research Organization with uniquely integrated offering which enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. Due to our continued growth we are seeking a Regulatory and Start Up Specialist based in the UK to join our growing team. Apart from the experience with regulatory submissions, candidates will ideally also have contracts and budgets negotiation experience for the UK. Essential functions of the job include but are not limited to: Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. * Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. * Interaction with CA/EC for study purposes and handling responses to the CA/EC. * Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team * Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership * Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. * Partner with the assigned site CRA to ensure alignment in communication and secure site * Review and manage collection of essential documents required for site activation/IMP release. * Customize country/site specific Patient Information Sheet and Informed Consent Form. * Responsible for/facilitates the translation and co-ordination of translations for documents. * Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. * Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. * When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. * May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. * Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. * Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF * May support the clinical team performing Pre-Study Site Visits. The ideal candidate will have: Minimum Required: * Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. * A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. * At least 2 years of relevant experience. Other Required: * Previous experience working as a Regulatory and Start Up Specialist or Site Contracts Specialists in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. * Strong communication and organizational skills. * Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. * Fluency in English Preferred: * Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. * Experience in site contract and budget negotiation would be a strong plus. * Experience using milestone tracking tools/systems. * Ability to prioritize workload to meet deadlines * Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science. #LI-TB1 #LI-Remote Any data provided as a part of this application will be stored in accordance with our [Privacy Policy.](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&reserved=0) For CA applicants, please also refer to our [CA Privacy Notice](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&reserved=0). [Precision Medicine Group](https://jobicy.com/company/precision-medicine-group.md) 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. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [myHR@precisionmedicinegrp.com](mailto:myHR@precisionmedicinegrp.com). Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [myHR@precisionmedicinegrp.com](mailto:myHR@precisionmedicinegrp.com) so we can investigate and take appropriate action. Candidates must be legally authorized to work in the country of employment without employer sponsorship. Show more [Apply now >](https://jobicy.com/jobs/161441-regulatory-and-start-up-specialist-2.md) > Annual salary information is not provided for this position. Explore salary ranges for similar roles in our [Salary Directory ›](https://jobicy.com/salaries.md) * ![Upload CV](data:image/svg+xml;base64,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) ### Upload your resume now To unlock remote work opportunities and be discovered by global employers. This job listing has been manually reviewed by the Jobicy Trust & Safety Team for compliance with our posting guidelines, including verification of the company's legitimacy, accuracy of job details, clarity of remote work policy, and absence of misleading or fraudulent content. ## Role DNA A quick view of the complexity, pace, ownership and collaboration implied by the job description. ### Job Complexity 4/5EasyHard ### Pace & Pressure 4/5RelaxedFast-paced ### Autonomy Level 4/5GuidedFull ownership ### Communication Load 4/5IndependentCollaborative AI insightThe role requires accurate interpretation of clinical-trial regulations, strict deadline management, and careful coordination across multiple internal and external stakeholders. Errors or delays in submissions, contracts, or essential documents can directly affect site activation timelines. ## Salary analysis Estimated compensation compared with the broader US market for similar roles. Estimated job median (per year)Highly competitive$65,000US market range (per year)$55k–$75k0$82.50k AI insightThe yearly pay period is inferred from the job context; it was not explicitly stated by the employer. No employer salary was disclosed. The annual compensation estimate is an AI-generated market estimate for a UK-based clinical regulatory and start-up specialist, presented in USD for comparison. ## Core skills Skills and capabilities most closely associated with this opportunity. [Clinical trial regulation](https://jobicy.com/jobs?search_keywords=Clinical%20trial%20regulation.md)[Regulatory submissions](https://jobicy.com/jobs?search_keywords=Regulatory%20submissions.md)[Site activation](https://jobicy.com/jobs?search_keywords=Site%20activation.md)[Ethics Committee submissions](https://jobicy.com/jobs?search_keywords=Ethics%20Committee%20submissions.md)[Competent Authority submissions](https://jobicy.com/jobs?search_keywords=Competent%20Authority%20submissions.md)[ICH-GCP](https://jobicy.com/jobs?search_keywords=ICH-GCP.md)[Clinical Trial Applications](https://jobicy.com/jobs?search_keywords=Clinical%20Trial%20Applications.md)[Site contract negotiation](https://jobicy.com/jobs?search_keywords=Site%20contract%20negotiation.md)[Budget negotiation](https://jobicy.com/jobs?search_keywords=Budget%20negotiation.md)[Essential document management](https://jobicy.com/jobs?search_keywords=Essential%20document%20management.md)[Trial Master File management](https://jobicy.com/jobs?search_keywords=Trial%20Master%20File%20management.md)[Regulatory intelligence](https://jobicy.com/jobs?search_keywords=Regulatory%20intelligence.md)[Project tracking](https://jobicy.com/jobs?search_keywords=Project%20tracking.md)[Clinical operations coordination](https://jobicy.com/jobs?search_keywords=Clinical%20operations%20coordination.md)[Audit readiness](https://jobicy.com/jobs?search_keywords=Audit%20readiness.md) Sample interview questionsHow have you managed a clinical trial submission to a Competent Authority or Ethics Committee?I begin by confirming country-specific requirements and the submission timeline, then compile and quality-check the application form, protocol documents, consent materials, and supporting records. I track questions and approvals closely, coordinate responses with the study team, and file final correspondence in the TMF. What steps do you take to keep site activation on schedule? I establish a site-level critical path with clear owners and dates for regulatory approval, contract negotiation, budget review, essential documents, and IMP requirements. I review progress frequently, identify blockers early, and escalate risks with practical mitigation options. How do you ensure informed consent materials are compliant for a specific country and site? I use approved global templates as a baseline, apply local regulatory and ethics requirements, coordinate certified translations where needed, and ensure version control is maintained. Before submission, I confirm that the materials align with the protocol and local review-body expectations. Describe your approach to supporting site contract and budget negotiations. I collect the relevant study assumptions and site requirements, identify items that need review by the contracts team, and maintain a transparent tracker of open points. I communicate clearly with sites and internal stakeholders to resolve issues without compromising required timelines or compliance. How do you maintain inspection readiness in a fast-moving start-up environment? I file documents contemporaneously, perform regular completeness and quality checks, and maintain clear version control and audit trails. I also use trackers to reconcile submissions, approvals, and site documents so that the TMF accurately reflects the current study status. Next step ## Apply now. Follow the employer’s application method and review Jobicy’s safety guidance before sharing personal information. 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