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ERGOMED

Study Start Up and Regulatory Affairs Specialist

ERGOMED

. Lead and coordinate activities required to achieve site initiation readiness .

Posted 9/30/2026full-timeRemote • New Zealand, United KingdomMid-LevelSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in regulatory compliance and study start-up processes, with a strong ability to develop regulatory strategies and manage documentation across multiple countries. Proven experience in liaising with stakeholders and ensuring adherence to ICH GCP and national regulations.

Highest-signal resume keywords
Regulatory ComplianceStudy Start-Up DocumentationRegulatory Strategies DevelopmentClinical Site Agreements ManagementICH GCP Knowledge

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Regulatory DocumentationStudy Start-Up ProcessesSubmissions ManagementEssential Documents PreparationTranslations ReviewRisk IdentificationRegulatory Milestones DeliveryJoint Operating Procedures DevelopmentCountry-Specific Requirements KnowledgeMedium-Complexity Regulatory Environments
Soft Skills
Independent Decision-MakingStakeholder LiaisonStrategic Input ProvisionQuality Control
Industry Keywords
Pharmaceutical IndustryCRO IndustryRegulatory Body ExperienceSSU PlansPatient Information SheetsInsurance DocumentationDiary CardsAncillary Agreements

About the role

Key responsibilities & impact
  • 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, 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 related documentation for compliance
  • Contribute to 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 strategies, SSU plans, joint operating procedures, and core documents
  • Identify and escalate project risks and support corrective/preventive actions
  • Perform other work-related duties as assigned

Requirements

What you’ll need
  • 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 SSU/Regulatory delivery in multiple countries within Europe and/or the Americas
  • Experience handling medium-complexity regulatory environments and multi-country requirements
  • Knowledge of regulatory and study start-up documentation, submissions, essential documents, translations, and country-specific requirements
  • Knowledge of clinical site agreements and ancillary agreements
  • Knowledge of labels, patient information sheets, diary cards, and insurance documentation
  • Ability to provide regulatory/SSU strategic input
  • Ability to develop regulatory strategies, SSU plans, joint operating procedures, and core documents

Benefits

Comp & perks
  • Full-time employment
  • Work remotely
  • Collaborative international team
  • Career growth opportunities
  • Flexible work-life balance
  • Opportunity to make an impact in rare disease and oncology clinical research
  • Passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting