Senior Regulatory Affairs Analyst – Project Feasibility Focus

LIBBS FARMACÊUTICA LTDA

Regulatory Affairs Analyst evaluating project feasibility for a pharmaceutical company and ensuring compliance with ANVISA regulations and guidelines. Collaborating with clinical research teams and external partners.

Posted 5/29/2026full-timeRemote • 🇧🇷 BrazilSeniorWebsite

About the role

Key responsibilities & impact

Assess the scope of new projects and, together with the clinical research, bioequivalence and medical information teams, determine the clinical-regulatory pathway to be adopted to enable approval of new projects.
Conduct due diligence on dossiers from international partners to determine or validate the project's clinical-regulatory strategy and manage identified risks.
Provide regulatory support to internal and external clients, clarifying questions regarding ANVISA regulations and requirements, and compliance with specific guidance for new product registration.
Proactively engage with partners to ensure their alignment with the regulatory strategy.
Participate in technical discussions representing the company with professional associations for public consultations, new regulatory frameworks and emerging technical requirements; assess the impact of new regulations and compile multidisciplinary contributions to protect the company's interests and manage products under your responsibility, as well as facilitate internal training and clarify regulatory questions.
Draft strategy-related proposals for constructive discussions with ANVISA or other regulatory authorities.
Contribute to the development and improvement of the area’s macro-processes and workflows, fostering technical discussions among analysts and interfacing departments to support the company's continuous improvement.

Requirements

What you’ll need

Bachelor's degree in Pharmacy, Biochemistry, Chemistry, Biology or Biomedicine is required.
Intermediate to advanced English.
Proficiency with Microsoft Office suite is required.
Proven experience in project feasibility processes, including defining the clinical-regulatory pathway for registration.
Knowledge and/or experience with international guidelines and standards (ICH, EMA, FDA).
Experience with registration of synthetic (chemical) drugs in Brazil is required.

Benefits

Comp & perks

Meal voucher (Vale Refeição).
Food allowance (Vale Alimentação).
Libbs medications – 100% coverage.
Pharmacy agreement – Vidalink.
PPR – Company Profit Sharing Program.
Parking, commuting allowance or company shuttle (applicable only for shift work).
USE Program: subsidy to purchase the equipment that will be used for work, which may also be used for personal purposes.
Flexible benefits (TotalPass), life insurance, private pension, health insurance, dental care and meal assistance.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

project feasibility processesclinical-regulatory pathwayregulatory supportdossier assessmentrisk managementproposal draftingmacro-process developmentworkflow improvementregistration of synthetic drugscompliance with ANVISA regulations

Soft Skills

proactive engagementtechnical discussioninterdepartmental communicationtraining facilitationcollaborationproblem-solvingstrategic thinkinganalytical skillsattention to detailstakeholder management