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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs with a focus on Medication Access Programs and compliance with ANVISA regulations. Proven ability to lead teams, manage stakeholder relationships, and ensure ethical execution of regulatory processes.
Highest-signal resume keywords
Regulatory Affairs ManagementMedication Access Programs ExperienceANVISA Regulations KnowledgeRegulatory Dossier PreparationStakeholder Management Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Submission Cycle ManagementPharmacovigilance ComplianceRegulatory Dossier CoordinationRegulatory Changes MonitoringTeam Training on Regulatory Procedures
Soft Skills
Relationship-Building SkillsOrganizational SkillsAnalytical SkillsStrategic ThinkingResults-Oriented Mindset
Industry Keywords
Pharmaceutical SectorRegulatory ComplianceGood Regulatory PracticesPrincipal Investigators CoordinationResearch Centers Collaboration
About the role
Key responsibilities & impact- Lead and oversee the Regulatory Affairs team.
- Manage and monitor the regulatory submission cycle for the PTA, CUP, and EAP Medication Access Programs with ANVISA.
- Ensure compliance with current legislation and the company’s internal policies.
- Serve as the focal point for regulatory authorities, internal and external stakeholders, principal investigators, and research centers.
- Coordinate and review regulatory dossiers and supporting documentation.
- Monitor national and international regulatory changes.
- Ensure the ethical and compliant execution of the programs, in accordance with pharmacovigilance requirements and good regulatory practices.
- Train and guide internal teams on regulatory requirements and procedures.
- Collaborate with Foreign Trade, Customer Service, Warehouse, Transportation, Procurement, and Sales teams.
- Report to the Director of Quality and Regulatory Affairs.
Requirements
What you’ll need- Bachelor’s degree in Pharmacy, Biomedicine, Medicine, Life Sciences, or a related field.
- Solid experience in Regulatory Affairs within the pharmaceutical sector.
- Mandatory experience with Medication Access Programs (PTA, CUP, and EAP) and Pharmacovigilance.
- In-depth knowledge of ANVISA regulations.
- Proven experience preparing and submitting regulatory dossiers.
- Strong relationship-building and stakeholder management skills, both internally and externally.
- Organized, analytical, strategic, and results-oriented profile.
- Experience managing people.
- Fluency in English is essential.
- Easy access to the southern area of São Paulo, SP, and availability to work on-site four days per week and remotely one day per week.
Benefits
Comp & perks- Dental insurance
- Grocery allowance
- Career development plan
- Profit-sharing bonus
- Medical insurance
- Meal voucher
- Transportation voucher
- Day off
- Partnership with Senac
- Life insurance
- Wellhub
- Partnership with Sesc