Regulatory Affairs Analyst – Mid-level

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Adeste

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1952

⚕️ Healthcare Insurance

Food • Healthcare Insurance • Pet Care

Adeste is a company that has been contributing to the progress of the food, health, animal nutrition, and pet care sectors since 1952, showcasing high competence in these areas. They focus on innovative solutions in health, creative food transformations, and providing nutritious, preservative-free treats for pets, ensuring the health and happiness of animals through quality products.

📋 Description

• 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).