Regulatory Affairs, Pharmacovigilance and PSP Analyst

Pinex

. Support the full cycle of regulatory submissions related to Patient Assistance Programs, in accordance with RDC 38/2013 and other applicable regulations .

Posted 10/23/2026full-timeSão Paulo • BrazilMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions and compliance for Patient Assistance Programs, with a strong focus on ANVISA regulations and pharmacovigilance activities. Capable of liaising with stakeholders and ensuring operational execution across various departments.

Highest-signal resume keywords

Regulatory SubmissionsANVISA RegulationsPharmacovigilanceAccess Programs (PTA, CUP, EAP)Clinical Research

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Dossier PreparationRegulatory ComplianceMonitoring Regulatory UpdatesExperience with Access ProgramsPharmacovigilance Activities

Soft Skills

Attention to DetailInterpersonal CommunicationOrganizational SkillsAnalytical Skills

Certifications & Qualifications

Bachelor's Degree in PharmacyBachelor's Degree in Biomedicine

Industry Keywords

Patient Assistance ProgramsRDC 38/2013Foreign TradeLogisticsCustomer ServiceProcurement

About the role

Key responsibilities & impact

Support the full cycle of regulatory submissions related to Patient Assistance Programs, in accordance with RDC 38/2013 and other applicable regulations
Assist with pharmacovigilance activities related to patient assistance programs
Prepare, review, and maintain up-to-date regulatory dossiers and supporting documentation
Liaise with ANVISA and other internal stakeholders to monitor processes and address regulatory inquiries
Monitor national and international regulatory updates related to access programs
Ensure compliance with legal, ethical, and compliance requirements
Support Foreign Trade, Logistics, Customer Service, and Procurement in the operational execution of the programs
Submit the annual report for each program
Work with PTA (Post-Study Access Program), EAP (Expanded Access Program), and CUP (Compassionate Use Program)

Requirements

What you’ll need

Bachelor's degree in Pharmacy, Biomedicine, or a related healthcare field
Previous experience with access programs and pharmacovigilance
Experience in Clinical Research
Knowledge of ANVISA regulations, particularly RDC 38/2013
Experience preparing and monitoring regulatory submissions
Previous experience with Access Programs (PTA, CUP, and EAP)
Organized and analytical profile, with strong attention to detail and interpersonal communication skills
Intermediate or advanced English is a plus
Experience in a multinational environment or interaction with global teams is a plus

Benefits

Comp & perks

Medical insurance
Dental insurance
Basic food basket
Career development plan
Profit-sharing bonus
Meal voucher
Transportation voucher
Day off
Partnership with Senac
Life insurance
Wellhub
Partnership with Sesc