[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 Site 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[Australia](https://jobicy.com/job-region/australia.md)SalaryUndisclosedDepartment[Healthcare & Medical](https://jobicy.com/categories/healthcare.md)EmploymentFull TimeExperienceSeniorPublished19 Oct 2026Apply before18 Nov 2026Listing views46Application actions1Application 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. Precision for Medicine ищет специалиста по регуляторным вопросам и запуску исследовательских центров для поддержки клинических исследований, преимущественно в онкологии и редких заболеваниях. Специалист будет готовить и сопровождать подачи в компетентные органы и этические комитеты, адаптировать информированные согласия и собирать essential documents для активации сайтов. Работа предполагает координацию с CRA, Clinical Operations, Regulatory, Project Management и командами контрактов, а также управление рисками и сроками запуска. Роль требует знания локальных норм клинических исследований, принципов ICH-GCP и уверенной работы с трекерами, электронными системами и документацией. ## 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 insightРоль требует практического знания регуляторных процедур, ICH-GCP и локальных требований к клиническим исследованиям. Сложность повышают параллельные сроки подачи документов, взаимодействие с регуляторами и необходимость предотвращать риски задержки активации сайтов. ## Salary analysis Estimated compensation compared with the broader US market for similar roles. Estimated job median (per year)Market rate$78,000US 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. Работодатель не раскрыл компенсацию. Для специалиста по regulatory и site start-up с опытом от одного года приведена ориентировочная годовая рыночная оценка в USD; период оплаты ежегодный inferred по стандартной практике для постоянной full-time роли. ## 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)[Ethics committee submissions](https://jobicy.com/jobs?search_keywords=Ethics%20committee%20submissions.md)[Informed consent forms](https://jobicy.com/jobs?search_keywords=Informed%20consent%20forms.md)[Essential document management](https://jobicy.com/jobs?search_keywords=Essential%20document%20management.md)[Site activation](https://jobicy.com/jobs?search_keywords=Site%20activation.md)[Regulatory intelligence](https://jobicy.com/jobs?search_keywords=Regulatory%20intelligence.md)[Clinical trial applications](https://jobicy.com/jobs?search_keywords=Clinical%20trial%20applications.md)[TMF management](https://jobicy.com/jobs?search_keywords=TMF%20management.md)[Risk mitigation](https://jobicy.com/jobs?search_keywords=Risk%20mitigation.md)[Milestone tracking](https://jobicy.com/jobs?search_keywords=Milestone%20tracking.md)[Contract negotiation support](https://jobicy.com/jobs?search_keywords=Contract%20negotiation%20support.md)[Cross-functional communication](https://jobicy.com/jobs?search_keywords=Cross-functional%20communication.md) Sample interview questionsHow do you manage a clinical trial submission to a competent authority or ethics committee?I begin by confirming country-specific requirements and building a submission checklist and timeline. I coordinate collection and quality review of all required documents, submit within the required timeline, track questions or deficiencies, and maintain clear records in the relevant systems and TMF. What steps would you take if a site activation milestone was at risk? I would identify the critical-path dependency, assess the root cause and impact, and immediately align with the site, CRA, and relevant internal functions. I would document a mitigation plan, escalate where needed, update the tracker, and provide stakeholders with a clear revised timeline. How do you ensure informed consent forms are compliant and suitable for a local site? I review the protocol, template language, country requirements, ethics committee expectations, and any required patient-facing adaptations. I coordinate translations and local review, ensure version control, and verify that the final form is consistent with the approved study documents. Describe how you maintain inspection readiness for start-up documentation. I file documents promptly according to the TMF plan, perform quality checks for completeness and consistency, and resolve discrepancies as they arise. I also maintain version control, submission evidence, approval records, and trackers so the history of each activation decision is readily traceable. How would you collaborate with site contract management when budgets or contracts delay activation? I would clarify the outstanding items, contractual dependencies, and site-specific deadlines with the contract management team and CRA. I would keep the activation critical path current, facilitate timely communication with the site when appropriate, and escalate risks early to protect the planned activation date. Opportunity details ## About this role. Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease. Due to our continued growth we are seeking a Regulatory and Site Start Up Specialist. The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and provide support to the Site Contract Management group in budget and contract negotiation. The RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities and may contribute to development or revision of country specific tools and guidance documents to ensure compliance with local and international clinical trials regulations and guidelines. 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 CA, EC, 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 as relevant. • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. • 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 collaboration. • Prepare. review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Forms. • Responsible for/facilitates the translation and co-ordination of translations for documents required for submission. • Maintain communication with other key functions participating to country start up i.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. • May support process improvement initiatives, training, and mentoring. • Performs other duties as assigned by management. Requirement: • 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. • 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. • Strong communication and organizational skills are essential. • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. • Fluency in English and for non-English speaking countries the local language of country where position based. Preferred: • Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country. • 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 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/155905-regulatory-and-site-start-up-specialist.md) > Annual salary information is not provided for this position. 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