[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 Review the role, location requirements, compensation details, and application process before deciding whether this opportunity fits your next career move. [Apply for this job](#job-application)[View company](https://jobicy.com/company/precision-medicine-group.md)ShareRemote from[Spain](https://jobicy.com/job-region/spain.md)SalaryUndisclosedDepartment[Healthcare & Medical](https://jobicy.com/categories/healthcare.md)EmploymentFull TimeExperienceSeniorPublished28 Oct 2026Apply before27 Nov 2026Listing views34Application actions3Application toolkit ## Make your next move. Prepare your resume, explore your fit, and draft a cover letter for this opportunity. AI Summary ## The role, at a glance. This role manages regulatory submissions and country-level site start-up activities for clinical trials in Spain. The specialist prepares Clinical Trial Application dossiers, coordinates with competent authorities and ethics committees, and maintains audit-ready trial documentation. It also supports site activation through essential-document collection, critical-path tracking, and collaboration with clinical operations, project management, and site contracts teams. Candidates need prior CRO, pharmaceutical, or biotechnology regulatory/start-up experience, contract and budget negotiation capability, and professional fluency in Spanish and English. Knowledge of Spanish clinical-trial requirements and ICH-GCP is central to success. ## 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 5/5IndependentCollaborative AI insightThe position requires specialized knowledge of clinical-trial regulations, submission processes, and site activation in Spain. It involves deadline-sensitive coordination across authorities, sites, and multiple internal functions while maintaining inspection readiness. ## Salary analysis Estimated compensation compared with the broader US market for similar roles. Estimated job median (per year)Highly competitive$80,000US market range (per year)$65k–$95k0$104.50k AI insightThe yearly pay period is inferred from the job context; it was not explicitly stated by the employer. No employer compensation was disclosed. The yearly cadence and USD estimates are inferred for an experienced clinical regulatory and site start-up specialist; they are indicative market estimates rather than employer-provided pay. ## Core skills Skills and capabilities most closely associated with this opportunity. [Clinical trial regulations](https://jobicy.com/jobs?search_keywords=Clinical%20trial%20regulations.md)[ICH-GCP](https://jobicy.com/jobs?search_keywords=ICH-GCP.md)[Regulatory submissions](https://jobicy.com/jobs?search_keywords=Regulatory%20submissions.md)[Clinical Trial Applications](https://jobicy.com/jobs?search_keywords=Clinical%20Trial%20Applications.md)[Ethics Committee submissions](https://jobicy.com/jobs?search_keywords=Ethics%20Committee%20submissions.md)[Site activation](https://jobicy.com/jobs?search_keywords=Site%20activation.md)[Study start-up](https://jobicy.com/jobs?search_keywords=Study%20start-up.md)[Investigator contract negotiation](https://jobicy.com/jobs?search_keywords=Investigator%20contract%20negotiation.md)[Clinical budget negotiation](https://jobicy.com/jobs?search_keywords=Clinical%20budget%20negotiation.md)[TMF management](https://jobicy.com/jobs?search_keywords=TMF%20management.md)[Regulatory intelligence](https://jobicy.com/jobs?search_keywords=Regulatory%20intelligence.md)[Milestone tracking](https://jobicy.com/jobs?search_keywords=Milestone%20tracking.md)[Essential document management](https://jobicy.com/jobs?search_keywords=Essential%20document%20management.md)[Spanish](https://jobicy.com/jobs?search_keywords=Spanish.md)[English](https://jobicy.com/jobs?search_keywords=English.md) Sample interview questionsHow have you managed a clinical trial application submission to a competent authority or ethics committee?I create a country-specific submission checklist, confirm document completeness and version control, coordinate required translations, and submit within the planned timeline. I track authority questions closely, coordinate accurate responses with the study team, and document all outcomes in the TMF and project tracker. What steps do you take to prevent delays in site activation? I establish a site-level critical path early, identify dependencies such as ethics approval, contract execution, budget agreement, and essential documents, and monitor each item through regular follow-up. When a risk emerges, I escalate it promptly and propose practical mitigation actions with the CRA, site contracts team, and project lead. Describe your approach to negotiating a study budget or investigator contract in Spain. I first understand the protocol workload, site requirements, and approved negotiation parameters. I communicate transparently with the site, document requested changes, involve the site contracts function where appropriate, and work toward an agreement that protects study timelines and complies with company and local requirements. How do you maintain audit and inspection readiness for start-up documentation? I file documents promptly according to the TMF plan, verify completeness and consistency against required checklists, and resolve discrepancies as soon as they are identified. I also maintain clear submission and approval records so the document history is traceable and readily available for review. How would you communicate a regulatory delay to a project team? I would provide a concise status update explaining the affected milestone, the reason for the delay, expected impact, actions already taken, and any decision or support needed from the team. I would continue updating the tracker and stakeholders until the issue is resolved and the revised timeline is confirmed. 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 Spain to join our growing team. Apart from the experience with regulatory submissions, for this role it’s key for candidates to have contracts and budgeting negotiation experience for Spain. 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. * Demonstrated experience in contracts and budgeting negotiation experience. Other Required: * Previous experience working as a Regulatory or Start Up specialist 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 and Spanish, fluency in Portuguese would be a strong plus. Preferred: * Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. * 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 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/157563-regulatory-and-start-up-specialist.md) > Annual salary information is not provided for this position. 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