Study Start Up and Regulatory Affairs Specialist

🕒 October 20

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 19%

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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 • Serve as liaison between 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, including submissions, essential documents, and translations • Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments • Review labels, patient information sheets, diary cards, insurance, and other documentation for ICH-GCP and country-specific compliance • 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 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 • Previous experience 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 specific country 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 medium-complexity projects • Ability to prepare, review, and quality-control regulatory and study start-up documentation • Knowledge of clinical site agreements, ancillary agreements, amendments, and country regulations • Ability to review labels, patient information sheets, diary cards, insurance, and related documentation • Ability to contribute to complex technical, scientific, and legal documentation • Ability to arrange and/or review translations of essential documents • Ability to develop regulatory strategies, Study Start-Up Plans, joint operating procedures, and core documents • Ability to identify and escalate project risks and support corrective/preventive actions

🏖️ Benefits

• Flexible/remote work arrangements (employees can work remotely) • Work-life balance • Career growth opportunities • Collaborative international team environment • Trusted ownership and autonomy • Opportunity to contribute to meaningful work helping bring safe and effective pharmaceutical treatments to patients

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