{"id":1126273,"url":"https://alion.io/job/ergomed-group-study-start-up-and-regulatory-affairs-specialist-2-years-plus-experience-5","title":"Study Start Up and Regulatory Affairs Specialist (2 years plus experience)","company":{"id":16046,"name":"Ergomed Group","domain":"ergomedgroup.com","url":"https://alion.io/company/ergomedgroup","size_band":"1001-5000","is_staffing_agency":false,"is_intermediary":false,"ats_vendor":"SmartRecruiters","truth_index":null},"role":"Public Policy","role_family":"Public Policy","seniority":"junior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","hiring_geo_confidence":"structured","locations":["Madrid, Spain"],"countries":["ES"],"hiring_countries":["ES"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":33000,"max_usd":59000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":29},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-09-22T14:57:26Z","employer_posted_date":"2026-09-22","last_verified_at":"2026-09-23T08:16:46Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Medicine moves forward here. So will you.\nErgomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.\nWe choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.\nThat is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported.\nIf you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.\n The Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities related\nto achieving site initiation readiness. The role provides subject matter expertise, ensures regulatory\ncompliance, and serves as a key liaison between internal teams, clients, and external stakeholders\nAccountable for delivery of assigned study start-up and regulatory milestones within defined scope.\nMake independent decisions within assigned scope regarding regulatory processes and documentation approaches.\nHandles medium-complexity regulatory environments, including multi-country requirements where applicable.\nLeads study start-up and regulatory activities for assigned countries or projects of medium complexity, ensuring delivery in line with timelines, quality standards, and regulatory requirements.\nLeads preparation, review, and quality control of regulatory and study start-up documentation (including submissions, essential documents, and translations) to ensure completeness, accuracy, and compliance with ICH-GCP and country-specific requirements.\nResponsible for drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements as well as amendments at country or regional level, in accordance with project requirements and country regulations and within the projected delivery timelines\nReview all relevant documentation e.g. labels, patient information sheets, diary cards, insurance etc, to ensure compliance with ICH GCP & country specific requirements.\nContribute towards the preparation and/or review of complex technical/scientific/legal documentation.\nArrange for and/or review translation of essential documents as required\nProvide regulatory/SSU strategic input to internal and external customers. Develop the regulatory strategy and the SSU Plan, joint operating procedures and core documents\nPromptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables; support corrective/preventive actions\nPerforms other work-related duties as assigned. \nGraduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience\nMinimum 2 years within pharmaceutical or CRO industry or Regulatory body\nGood knowledge of ICH GCP and national regulations for territories of competency \nGood understanding of specific country requirements pertaining to SSU/Regulatory delivery in multiple countries within Europe and/or the Americas\n When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.\nWe are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.\nQuality: we hold ourselves to the standard patients deserve. \nIntegrity and trust: we do the right thing, especially when it is hard. \nDrive and passion: we care about the outcome, because someone is waiting on it. \nAgility and responsiveness: we move quickly, because patients cannot wait. \nBelonging: everyone is welcome, and every voice counts. \nCollaborative partnerships: we go further by going together. \nWe look forward to welcoming your application.","description_format":"text","description_chars":4690,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Spain","iso":"ES","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Professional Services"],"lifecycle":[{"event":"open","at":"2026-09-22T21:45:21Z"}],"liveness":{"score":95,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.946,"p_room":1,"age_days":0,"expected_fill_days":13,"reasons":["conf:7","wave","win:early","comp:junior"],"computed_at":"2026-09-23T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/ergomed-group-study-start-up-and-regulatory-affairs-specialist-2-years-plus-experience-5","json_url":"https://alion.io/job/ergomed-group-study-start-up-and-regulatory-affairs-specialist-2-years-plus-experience-5.json","meta":{"generated_at":"2026-09-23T15:43:53Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}