Pinex

Regulatory Affairs Manager

Pinex

full-time

Posted on:

Location Type: Hybrid

Location: São Paulo • Brazil

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About the role

  • 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

  • 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
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

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