Study Start Up and Regulatory Affairs Specialist

🔥 1 minute ago

🇨🇿 Czechia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 18%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Lead and coordinate activities required to achieve site initiation readiness • Provide subject matter expertise and ensure regulatory compliance • Liaise with internal teams, clients, and external stakeholders • Deliver assigned study start-up and regulatory milestones within defined scope • Handle medium-complexity regulatory environments, including multi-country requirements where applicable • Lead study start-up and regulatory activities for assigned countries or medium-complexity projects • Prepare, review, and quality-control regulatory and study start-up documentation, including submissions, essential documents, and translations • Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments at country or regional level • Review labels, patient information sheets, diary cards, insurance, and other documentation for ICH-GCP and country-specific compliance • Contribute to preparation and/or review of complex technical, scientific, and legal documentation • Arrange and/or review translations of essential documents • Provide regulatory and study start-up strategic input to internal and external customers • Develop regulatory strategy, study start-up plans, joint operating procedures, and core documents • Identify and escalate risks that may jeopardize project deliverables and support corrective/preventive actions • Perform other work-related duties as assigned

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience • Minimum 2 years within the pharmaceutical or CRO industry or a regulatory body • Good knowledge of ICH GCP and national regulations for territories of competency • Good understanding of country-specific requirements pertaining to study start-up/regulatory delivery in multiple countries within Europe and/or the Americas • Ability to lead study start-up and regulatory activities for assigned countries or projects of medium complexity • Knowledge of regulatory and study start-up documentation, submissions, essential documents, and translations • Knowledge of clinical site agreements, ancillary agreements, and amendments • Knowledge of labels, patient information sheets, diary cards, insurance, and related documentation • Ability to contribute to complex technical, scientific, and legal documentation • Regulatory and study start-up strategic planning knowledge • Ability to identify and escalate project risks and support corrective/preventive actions • Ability to make independent decisions within assigned scope regarding regulatory processes and documentation approaches

🏖️ Benefits

• Remote work option • Work-life balance • Collaborative, international team environment • Career growth opportunities • Opportunity to take ownership early • Supportive workplace culture • Passionate and collaborative team of experts • Values-driven work environment • Opportunity to help bring safe and effective pharmaceutical treatments to patients