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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in coordinating regulatory submissions and correspondence, ensuring quality control and compliance with formatting standards. Proficient in managing administrative tasks and liaising with finance for regulatory fee payments.
Highest-signal resume keywords
Regulatory Submission CoordinationQuality Control of DocumentsCRO/Pharmaceutical Industry ExperienceBachelor's Degree or EquivalentFluent in Local Language
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Document FormattingAdministrative SupportRegulatory CorrespondenceSubmission TrackingFee Payment Coordination
Soft Skills
CommunicationOrganizational SkillsAttention to Detail
Tools & Technologies
Tracking Tools
Industry Keywords
CROPharmaceuticalRegulatory Authorities
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