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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory documentation preparation, analysis, and compliance, with a strong focus on monitoring regulatory changes and ensuring adherence to safety and quality standards. Proficient in conducting audits, technovigilance activities, and providing regulatory guidance to internal teams and clients.
Highest-signal resume keywords
Regulatory Documentation PreparationRegulatory Compliance MonitoringTechnovigilance ActivitiesSafety Data Sheet PreparationIntermediate English Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory DocumentationDossier PreparationRegulatory Requirements AssessmentInternal AuditsSafety Data SheetsProduct RegistrationRegulatory ReportingLabeling ReviewTechnical File ManagementERP Systems
Soft Skills
Strong Organizational SkillsProactive ApproachAnalytical SkillsStrong Communication SkillsInterpersonal Skills
Certifications & Qualifications
Bachelor’s Degree in PharmacyExtension Course in Healthcare Regulatory Affairs
Industry Keywords
Regulatory AffairsHealth InspectionsControlled ChemicalsANVISACorporate Registration
Tech Stack
Tools & technologiesERP
About the role
Key responsibilities & impact- Prepare, analyze, organize, and renew regulatory documentation for low-, medium-, and high-complexity portfolios
- Monitor and interpret regulatory changes, ensuring that processes are kept up to date and that changes are implemented in practice
- Assess regulatory requirements for new products and the current portfolio
- Prepare and review notification, registration, post-registration, and revalidation dossiers
- Respond to requirements issued by regulatory agencies
- Monitor regulatory deadlines and processes
- Perform technovigilance activities, including investigations and reporting to ANVISA
- Review advertising and promotional materials in accordance with current regulations
- Prepare Safety Data Sheets based on manufacturers’ documentation
- Review labeling, instructions for use, and manuals
- Keep technical files up to date and compliant
- Advise internal departments and clients on regulatory matters
- Provide support during health inspections and audits
- Conduct internal audits and address potential nonconformities
- Develop letters, statements, and guidance materials on regulations and good practices
- Monitor and arrange the renewal of corporate registration documents and registrations with professional councils
- Update product registration information in ERP systems
- Issue Certificates of Non-Production and Declarations of Exclusivity
- Submit monitoring reports on the use and sale of controlled chemicals to regulatory authorities
Requirements
What you’ll need- Bachelor’s degree in Pharmacy, Biology, Biomedicine, or a related field
- Extension course in healthcare regulatory affairs
- Intermediate English proficiency
- Proactive approach
- Strong organizational skills
- Ability to adapt to regulatory changes
- Initiative
- Analytical skills
- Strong communication and interpersonal skills
- This position is also open to people with disabilities and professionals of all beliefs, backgrounds, races, sexual orientations, and gender identities
Benefits
Comp & perks- Medical insurance (Unimed) and dental insurance (Dental Uni)
- Pet health insurance
- Wellhub (formerly Gympass)
- Workplace exercise program
- Clube Gazeta
- Professional development opportunities
- Quality of life programs
- Birthday gift card
- Meal voucher
- Food allowance
- Transportation voucher (in accordance with applicable law)
- Brasil Convênios
- On-site parking
- Childcare assistance (for children up to 5 years and 11 months old)
- Maternity and paternity welcome kit
- 8-hour workday, with the option to adjust start and end times between 7:30 a.m. and 6:00 p.m.
- Hybrid work arrangement, Monday through Friday
- Corporate University
- Education and language scholarship program
- Life insurance—with no employee payroll deduction
- Profit-Sharing Program