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Core
Support regulatory and administrative activities for the Regulatory Affairs team, ensuring documentation organization, tracking regulatory requirements, and supporting processes with ANVISA.
Role type
Regulatory Affairs Intern
Builds
Regulatory documentation and process support for pharmaceutical products
Domain
Healthcare / Pharmaceuticals
Deliverable
dashboards & analysis
Required skills
Regulatory process tracking, documentation management, data entry, translation coordination, audit support, SAP system usage, Office suite proficiency
Preferred skills
Portuguese (native), English (intermediate)
Responsibilities
Support review, update, and submission of drug leaflets and labeling to ANVISA; Create and control packing scripts and regulatory art tracking spreadsheets; Maintain regulatory process control spreadsheets; Organize physical and electronic documentation; Assist in certification apostille and renewal processes; Handle payment requests and tracking in SAP; Manage translation requests and document flow with vendors; Support purchase and control of administrative materials; Conduct brand searches in POCA/ANVISA systems; Monitor ANVISA Electronic Bulário and Official Gazette updates; Support internal and external audits and inspections; Participate in regulatory meetings with ANVISA and industry entities; Assist in submitting regulatory processes like HMP for clone medicines and BSPO reports.
Seniority
Intern
