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Assistant Regulatory Affairs – LATAM
LifelancerAssisting with regulatory affairs for clinical trials in LATAM within a global CRO. Coordinating documentation and ensuring compliance with regulatory standards.
About the role
Key responsibilities & impact- Assist with the coordination of translation of regulatory correspondence and submission documents such as protocols, synopsis, ICF and labels
- Pack and dispatch regulatory submissions, site contracts, and site documents, follow up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools
- Perform administrative QC of regulatory submissions, site documents and site contracts to ensure correct completeness and formatting
- Liaise with Finance requesting fee payment to Regulatory Authorities. Closely monitor the assigned Therapeutic mailbox and triage requests to the correct team members for prompt action
Requirements
What you’ll need- 2 years office/business experience in a supporting role
- Preferable CRO/pharmaceutical industry experience
- Bachelor’s degree or equivalent preferred
- Fluent in local language; working knowledge of English
Benefits
Comp & perks- Competitive salary
- Flexible work hours
- Professional development budget
- Home office setup allowance
- Global team events
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Document FormattingAdministrative SupportRegulatory CorrespondenceSubmission TrackingFee Payment Coordination
Soft Skills
CommunicationOrganizational SkillsAttention to Detail