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Regulatory and Start Up Specialist
Precision For Medicine. Deliver timely, high-quality site activation readiness for assigned countries/sites and foresee and mitigate 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 compliance with local clinical trial laws. Proficient in managing essential documents and facilitating communication among cross-functional teams to ensure timely project execution.
Highest-signal resume keywords
Regulatory SubmissionsSite Activation ProcessesProject ManagementSite Contract NegotiationClinical Trial Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial Application PreparationRegulatory Intelligence ToolsEssential Document ReviewPatient Information Sheet CustomizationInformed Consent Form CustomizationMilestone Tracking ToolsSite Activation Data ManagementFeasibility Site OutreachBudget NegotiationAudit/Inspection Readiness
Soft Skills
Strong Communication SkillsOrganizational Skills
Tools & Technologies
Computerized Information SystemsElectronic SpreadsheetsWord ProcessingElectronic Mail
Certifications & Qualifications
RAC CertificationQualification in Pharmacy
Industry Keywords
CROPharmaceutical IndustryBiotech IndustryClinical OperationsEthics CommitteesCompetent AuthoritiesSite ContractsInvestigator ContractsPre-Study Site VisitsTMF
About the role
Key responsibilities & impact- Deliver timely, high-quality site activation readiness for assigned countries/sites and foresee and mitigate risks
- Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies
- Interact with Competent Authorities and Ethics Committees and handle responses
- Provide regular submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams
- Maintain project plans, project trackers, regulatory intelligence tools, and site activation data
- Support study-specific start-up plans, IMP release requirements, and essential document review criteria
- Partner with site CRAs to align communications 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 teams
- Support site contract and budget negotiations and execution of investigator contracts
- Support feasibility site outreach and Pre-Study Site Visits when required
- Maintain knowledge of local clinical trial laws and regulations and share knowledge within PFM
- Maintain audit/inspection readiness and file documents in the relevant TMF
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
- Strong communication and organizational skills
- Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail
- Fluency in English
- Legally authorized to work in the country of employment without employer sponsorship
- Qualification in Pharmacy or work experience as a Pharmacist highly beneficial
- Relevant regulatory and site start-up experience preferred
- Site contract and budget negotiation experience preferred
- Experience using milestone tracking tools/systems preferred
- Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science preferred
Benefits
Comp & perks- Regular full-time employment
- Remote work arrangement
- Equal Opportunity Employer
- Reasonable accommodation available for applicants with disabilities