Regulatory Affairs Analyst – Mid-level

Role Overview

• Monitor, interpret, and analyze national and international laws, regulations, and regulatory guidance, evaluating their impacts on the business.
• Ensure regulatory compliance of Active Pharmaceutical Ingredients (APIs), biological products, medicines, ingredients, food additives, and foods, as applicable to the company’s portfolio.
• Prepare, review, and maintain regulatory dossiers for ANVISA and other national and international regulatory authorities.
• Prepare and update technical documentation in CTD format, including Drug Master File (DMF) and other regulatory documents.
• Participate in technical discussions for regulatory feasibility assessments of new projects, new products, and process changes.
• Manage post-approval regulatory processes, including variations, additions, adaptations, and renewals, ensuring compliance with legal requirements.
• Develop regulatory intelligence analyses, identifying trends, opportunities, and risks to support company strategy.
• Identify and mitigate regulatory risks, proposing technical and regulatory solutions to ensure business continuity.
• Coordinate the collection of information from technical areas for the preparation of protocols, reports, and regulatory documentation.
• Oversee the renewal of licenses, permits, operating authorizations, certificates, and other mandatory documents with regulatory authorities.
• Provide technical support during internal audits, health authority inspections, and client audits.
• Act as the interface between internal departments and regulatory authorities, promoting technical and regulatory alignment.

Requirements

• Bachelor’s degree in Pharmacy, Biotechnology, or a related field.
• Experience in Regulatory Affairs within the pharmaceutical industry.
• Experience with regulatory processes before ANVISA.
• Experience preparing regulatory dossiers and technical documentation in CTD/DMF format.
• Knowledge of regulations applicable to Active Pharmaceutical Ingredients (APIs), preferably of biological origin.
• Experience performing regulatory impact assessments.
• Intermediate English (reading, writing, and interpretation of technical documents).

Benefits

• We value diversity and work to promote an inclusive culture.
• Position also open to candidates with disabilities (PwD).
• Remote work (home office).