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Regulatory and Start Up Specialist
Precision Medicine Group. Deliver timely and high-quality site activation readiness for assigned countries and sites while identifying and mitigating risks .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory submissions, site activation processes, and clinical trial management, with a strong focus on compliance with local laws and regulations. Proficient in project management and communication across multidisciplinary teams to ensure timely and effective site readiness.
Highest-signal resume keywords
Regulatory SubmissionsSite Activation ReadinessContract NegotiationClinical Trial Application PreparationProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory SubmissionsSite ActivationFeasibility AssessmentBudget NegotiationClinical Trial Application PreparationEssential Document ReviewPatient Information Sheet CustomizationInformed Consent Form CustomizationMilestone TrackingAudit Readiness
Soft Skills
CommunicationCollaborationRisk MitigationProblem SolvingInterpersonal Skills
Tools & Technologies
Regulatory Intelligence ToolsProject TrackersComputerized Information SystemsElectronic SpreadsheetsWord Processing Software
Certifications & Qualifications
RAC CertificationAdvanced Degree in Medical or Life Sciences
Industry Keywords
CROPharmaceuticalBiotechCompetent AuthoritiesEthics CommitteesIRBTMFSite Contracts ManagementClinical OperationsInvestigator Contract Execution
About the role
Key responsibilities & impact- Deliver timely and high-quality site activation readiness for assigned countries and sites while identifying and mitigating risks
- Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other applicable local bodies
- Interact with Competent Authorities and Ethics Committees and handle responses
- Provide regular submission updates to Start Up Leads, Regulatory Leads, Project Managers, and project teams
- Maintain project plans, project trackers, and regulatory intelligence tools
- Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria
- Partner with assigned site CRAs to align communication and secure site activation
- Review and manage essential documents required for site activation and IMP release
- Customize country/site-specific Patient Information Sheets and Informed Consent Forms
- Coordinate document translations
- Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts Management teams regarding status and deliverables
- Maintain site-level critical path data for Competent Authority, IRB/Ethics Committee timelines, site contracts, budget negotiations, and other reviews
- Support study budget negotiations and investigator contract execution
- Support feasibility activities and site outreach
- Maintain knowledge of local clinical trial laws and regulations and share knowledge within Precision for Medicine
- Maintain audit and inspection readiness and file documents according to TMF and study-specific plans
- Support clinical teams performing Pre-Study Site Visits
Requirements
What you’ll need- Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience
- At least 2 years of relevant experience
- Previous experience as a Regulatory and Start Up Specialist or Site Contracts Specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies
- Experience with regulatory submissions
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
- Fluency in English
- Relevant regulatory and site start-up experience, including feasibility, contract negotiations, and CA/EC/IRB submissions
- Experience in site contract and budget negotiation would be a strong plus
- Experience using milestone tracking tools/systems
- Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science are preferred
- Must be legally authorized to work in the country of employment without employer sponsorship
Benefits
Comp & perks- Regular full-time employment
- Remote work arrangement
- Equal Opportunity Employer
- Reasonable accommodation available during the application process