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Regulatory Affairs Analyst – Mid-level
Location
Brazil
Posted
3 days ago
Salary
0
Seniority
Senior
Job Description
Regulatory Affairs Analyst – Mid-level
Adeste
• 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.
Job 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).
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