Senior Specialist, Study Start Up and Regulatory Affairs

🔥 0 minutes ago

🌐 Serbia, Czechia – Remote

🇷🇸 Serbia – Remote 🇨🇿 Czechia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 15%

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 • Make independent decisions regarding regulatory processes and documentation approaches • 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 • Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments • Review labels, patient information sheets, diary cards, insurance, and other documentation for compliance • Arrange and review translations of essential documents • Provide regulatory and study start-up strategic input to internal and external customers • Develop regulatory strategies, study start-up plans, joint operating procedures, and core documents • Identify and escalate project risks and support corrective and 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 4 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 for study start-up and regulatory delivery in multiple countries within Europe and/or the Americas • Subject matter expertise in regulatory affairs and study start-up • Ability to handle medium-complexity regulatory environments and multi-country requirements • Ability to work with regulatory and study start-up documentation, submissions, essential documents, and translations • Knowledge of clinical site agreements and ancillary agreements • Ability to review labels, patient information sheets, diary cards, insurance, and related documentation for compliance • Ability to contribute to complex technical, scientific, and legal documentation

🏖️ Benefits

• Collaborative, international team environment • Flexible work arrangements • Work-life balance • Career growth opportunities • Opportunity to take ownership early • Work with purpose and make an impact • Passionate and collaborative team of experts • Diverse and inclusive workplace where every voice counts