Regulatory Affairs Manager

Pinex

Regulatory Affairs Manager coordinating regulatory submissions and compliance for Patient Assistance Programs in Brazil. Collaborating with stakeholders on program execution while ensuring ethical standards.

Posted 4/12/2026full-timeSão Paulo • 🇧🇷 BrazilMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Manage the full cycle of regulatory submissions related to Patient Assistance Programs (Post-Trial Access, Compassionate Use, and Expanded Access) to ANVISA, in accordance with RDC 38/2013 and other applicable regulations.
Ensure compliance with applicable legislation and company internal policies.
Serve as the main point of contact with regulatory authorities, internal and external stakeholders, principal investigators, and research centers.
Coordinate and review regulatory dossiers and supporting documentation for patient assistance programs.
Monitor national and international regulatory changes related to access programs.
Ensure the ethical and compliant execution of programs, in line with pharmacovigilance requirements and regulatory best practices.
Train and guide internal teams on regulatory requirements and procedures applicable to the programs.
Collaborate with Foreign Trade, Customer Service, Warehouse, Transportation, Procurement, and Commercial teams in program execution.

Requirements

What you’ll need

University degree in Pharmacy, Biomedicine, Medicine, Life Sciences, or related fields.
Solid experience in Regulatory Affairs within the pharmaceutical sector, preferably with Access Programs (PTA, CUP, EAP).
In-depth knowledge of ANVISA regulations.
Proven experience preparing and submitting regulatory dossiers.
Strong ability to manage relationships with internal and external stakeholders.
Organized, analytical, strategic, and results-oriented profile.
Experience in people management.
Fluent in English.

Benefits

Comp & perks

Medical insurance
Dental insurance
Christmas hamper
Career development plan
Life insurance
Meal allowance
Transportation allowance
Day off
Partnership with SENAC
Profit sharing (PLR)
Partnership with SESC
WellHub

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsregulatory dossierspharmacovigilanceANVISA regulationsAccess ProgramsPost-Trial AccessCompassionate UseExpanded Accessregulatory complianceregulatory best practices

Soft Skills

relationship managementorganizational skillsanalytical skillsstrategic thinkingresults-orientedpeople managementcommunication skillstraining and guidancecollaborationstakeholder engagement