[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 (Portuguese speaker) 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[Legal & Compliance](https://jobicy.com/categories/legal.md)EmploymentFull TimeExperienceSeniorPublished28 Oct 2026Apply before27 Nov 2026Listing views47Application actions4Application 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 and site start-up activities for clinical trials in Spain within a global CRO. Key work includes preparing submissions to competent authorities and ethics committees, maintaining activation documentation, and monitoring critical-path milestones. The specialist will also support study budget and investigator-contract negotiations while coordinating with clinical operations, project management, feasibility, and site teams. Candidates need clinical-trial regulatory experience, strong knowledge of ICH-GCP and local requirements, and fluency in English and Portuguese. The position requires careful documentation, deadline management, and proactive risk mitigation to enable timely site activation. ## 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 role combines regulated clinical-trial submissions, country-specific start-up requirements, document control, and contract or budget support. Errors or delays can affect trial activation timelines, so it requires experienced judgment and precise cross-functional coordination. ## Salary analysis Estimated compensation compared with the broader US market for similar roles. Estimated job median (per year)Highly competitive$105,000US market range (per year)$85k–$125k0$137.50k 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-trial regulatory and start-up specialist; they are market estimates rather than stated employer pay. ## Core skills Skills and capabilities most closely associated with this opportunity. [Clinical trial start-up](https://jobicy.com/jobs?search_keywords=Clinical%20trial%20start-up.md)[Regulatory submissions](https://jobicy.com/jobs?search_keywords=Regulatory%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)[Ethics committee submissions](https://jobicy.com/jobs?search_keywords=Ethics%20committee%20submissions.md)[Competent authority interactions](https://jobicy.com/jobs?search_keywords=Competent%20authority%20interactions.md)[Site activation](https://jobicy.com/jobs?search_keywords=Site%20activation.md)[Investigator contract negotiation](https://jobicy.com/jobs?search_keywords=Investigator%20contract%20negotiation.md)[Clinical trial budget negotiation](https://jobicy.com/jobs?search_keywords=Clinical%20trial%20budget%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)[Milestone tracking](https://jobicy.com/jobs?search_keywords=Milestone%20tracking.md)[Portuguese language proficiency](https://jobicy.com/jobs?search_keywords=Portuguese%20language%20proficiency.md)[Cross-functional coordination](https://jobicy.com/jobs?search_keywords=Cross-functional%20coordination.md) Sample interview questionsHow do you manage a clinical trial submission to a competent authority or ethics committee?I begin by confirming local requirements and the study timeline, then create a submission checklist covering the protocol, informed-consent materials, investigator documents, translations, and required forms. I conduct a quality review before submission, track authority questions and due dates, and keep the study team updated until approval is received and filed. Describe your approach to negotiating a site budget and investigator contract. I review the protocol schedule of assessments, local standard-of-care costs, site feasibility needs, and sponsor budget parameters. I communicate transparently with site contacts, document requested changes and rationale, escalate material deviations appropriately, and work toward terms that protect timelines, compliance, and the study budget. How would you reduce the risk of delayed site activation? I establish a country and site-level critical path early, identify dependencies such as regulatory approval, contract execution, budget approval, and IMP release, and monitor them in a tracker. I hold regular follow-ups with sites and internal stakeholders, flag risks early, and propose practical mitigation actions with clear owners and deadlines. What is your experience with informed consent forms and patient-facing materials? I ensure country and site-specific versions meet applicable regulatory and ethics requirements, reflect the approved protocol, and are understandable for participants. I coordinate qualified translations, verify version control, manage review comments, and ensure final approved documents are available before enrolment activities begin. How do you ensure inspection readiness for start-up documents? I file documents promptly in the TMF according to the TMF plan and perform routine completeness and quality checks. I maintain clear version history, ensure approvals and correspondence are retrievable, resolve filing gaps quickly, and follow SOPs so the record accurately demonstrates compliant start-up execution. 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 and be fluent in Portuguese language. 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, on top of experience related to regulatory submissions. * Fluency in English and Portuguese 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. 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/157565-regulatory-and-start-up-specialist-portuguese-speaker.md) > Annual salary information is not provided for this position. 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