FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory compliance and study start-up processes, with a strong focus on ICH-GCP standards and multi-country regulatory requirements. Capable of leading documentation preparation, risk identification, and strategic input for clinical projects.
Highest-signal resume keywords
Regulatory ComplianceStudy Start-Up ExpertiseICH-GCP KnowledgeClinical Site AgreementsRisk Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory DocumentationStudy Start-Up PlansSubmissionsEssential DocumentsTranslationsTechnical DocumentationScientific DocumentationLegal DocumentationCountry-Specific RequirementsMulti-Country Regulatory Delivery
Soft Skills
Independent Decision-MakingLiaison SkillsStrategic InputQuality ControlRisk Escalation
Certifications & Qualifications
Graduate Degree in Chemistry or Life SciencesNursing Degree
Industry Keywords
Pharmaceutical IndustryCRO IndustryRegulatory BodyClinical TrialsStudy Start-Up
About the role
Key responsibilities & impact- Lead and coordinate activities required to achieve site initiation readiness
- Provide subject matter expertise and ensure regulatory compliance
- Serve as a 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 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 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 strategies, study start-up plans, joint operating procedures, and core documents
- Identify and escalate risks that may jeopardize deliverables and support corrective/preventive actions
- Perform other assigned work-related duties
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
- Subject matter expertise in study start-up and regulatory affairs
- Ability to handle medium-complexity regulatory environments, including 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
- Ability to review labels, patient information sheets, diary cards, insurance, and related documentation for compliance
- Knowledge of technical, scientific, and legal documentation
- Ability to provide regulatory/SSU strategic input
- Ability to identify and escalate project risks and support corrective/preventive actions
Benefits
Comp & perks- Flexible/remote work arrangements
- Work-life balance
- Collaborative international team environment
- Career growth opportunities
- Trusted ownership and agility to make an impact
- Supportive workplace culture
- Opportunity to contribute to bringing safe and effective pharmaceutical treatments to patients
- Diverse and inclusive workplace where every voice counts