LIBBS FARMACÊUTICA LTDA

Mid-level Regulatory Affairs Analyst – New Registrations

LIBBS FARMACÊUTICA LTDA

full-time

Posted on:

Location Type: Remote

Location: Brazil

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About the role

  • Ensure compliance with current regulations in registration dossiers through the preparation and review of regulatory-technical documents, assessing associated risks and proposing mitigation strategies.
  • Participate from product development and registration stages through to product launch, supporting the team and cross-functional areas.
  • Ensure compliance with current regulations in commercial/licensing partner dossiers by performing regulatory-focused due diligence, assessing risks and defining mitigation strategies.
  • Contribute to responding to regulatory queries by analyzing questions and developing regulatory-technical strategies to meet ANVISA expectations together with external partners (in the case of a licensee) and/or internal partners (for in-house development projects).
  • Assist in regulatory-technical meetings with ANVISA or other regulatory authorities, when necessary, by preparing strategy and materials together with internal stakeholders.
  • Contribute to the investigation of quality deviations and the development of strategies and action plans that ensure compliance with current regulations, with a regulatory-technical focus.
  • Contribute to regulatory-technical discussions with industry associations and/or ANVISA by proposing initiatives that can shape the regulatory environment.
  • Provide regulatory support to internal clients by supplying information on products under your responsibility, clarifying ANVISA regulations and supporting technical discussions to assess regulatory impact.
  • Contribute to project governance by keeping information updated in the core team’s control and tracking tools.
  • Prepare dossiers and submit registration applications in accordance with applicable regulations.

Requirements

  • Bachelor's degree required in Pharmacy, Biochemistry, Chemistry, Biology or Biomedicine.
  • Intermediate English.
  • Proficiency in Microsoft Office.
  • Knowledge and/or experience with international guidelines and regulations (ICH, EMA, FDA).
  • Experience with registration of synthetic (small-molecule) medicines in Brazil is required.
  • Experience preparing and submitting CTD (Common Technical Document) registration dossiers is required.
  • Experience performing regulatory technical review of CMC/quality documentation for registration, assessing risks and proposing mitigation strategies is required.
  • Experience responding to regulatory queries/deficiencies by analyzing questions and developing technical and regulatory strategies together with internal and external development teams is required.
  • Experience working with international partners, ensuring compliance in licensing dossiers through regulatory-focused due diligence, assessing risks and defining mitigation strategies is required.
  • Knowledge of analytical method development and validation, drug stability, bioequivalence studies and dissolution profiles, ANVISA regulations related to drug quality (for example: RDC 53/15, RDC 964/25, RDC 31/10, RDC 318/19, RDC 166/17), pharmaceutical processes and drug development is required.
  • Desirable: knowledge of Project Management and Agile methodologies.
  • Preferred courses: postgraduate studies in Regulatory Affairs, Analytical Development, Pharmaceutical/Formulation Development and Technical Documentation.
  • Desirable: experience with biological products (higher complexity), monoclonal antibodies and vaccines.
  • Knowledge of other product categories (e.g., food, medical devices) will be considered a differential.
Benefits
  • Meal voucher.
  • Grocery allowance.
  • Libbs medicines – 100% coverage.
  • Pharmacy agreement – Vidalink.
  • PPR - Company Profit and Results Sharing Program.
  • Parking, commuting allowance or company shuttle (applicable only for shift work).
  • USE Program: subsidy for purchasing equipment to be used for work, which may also be used for personal purposes.
  • Flexible benefits (TotalPass, life insurance, private pension, health care, dental care and meal allowance).
Applicant Tracking System Keywords

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

Hard Skills & Tools
regulatory-technical documentsrisk assessmentmitigation strategiesregistration of synthetic medicinesCTD registration dossiersregulatory technical reviewanalytical method developmentdrug stabilitybioequivalence studiespharmaceutical processes
Soft Skills
communicationcollaborationproblem-solvinganalytical thinkingproject governance
Certifications
Bachelor's degree in PharmacyBachelor's degree in BiochemistryBachelor's degree in ChemistryBachelor's degree in BiologyBachelor's degree in Biomedicinepostgraduate studies in Regulatory Affairspostgraduate studies in Analytical Developmentpostgraduate studies in Pharmaceutical Developmentpostgraduate studies in Technical Documentation