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Job Title: Regulatory Affairs (RA) AnalystAbout the PositionThe Regulatory Affairs Analyst will be responsible for managing regulatory submissions and ensuring compliance with local and international regulatory requirements. This role plays a key part in supporting new product registrations, post-marketing activities, and regulatory strategy execution within the pharmaceutical domain.Key Roles & ResponsibilitiesPrepare, review, and submit high-quality CTD dossiers for new drug product registrations and post-marketing variations in compliance with regulatory requirements.Prepare and respond to Deficiency Letters issued by ANVISA, ensuring timely and accurate submissions.Conduct risk assessments and gap analyses to enhance regulatory processes and improve dossier quality.Develop and implement regulatory strategies for Pharmaceutical Equivalence Studies and Biowaivers, including coordination of outsourcing activities.Support and monitor the importation process in line with regulatory compliance requirements.Evaluate regulatory feasibility and identify potential risks or requirements to support project execution.Qualifications & ExperienceMinimum 5 years of experience in Regulatory Affairs or Technical Documentation within the pharmaceutical industry.Bachelor’s degree or higher in Pharmacy, Chemistry, Biology, Biomedicine, or a related field.Strong working knowledge of ANVISA regulations, as well as international regulatory guidelines and processes.Proven ability to manage regulatory documentation with accuracy, attention to detail, and compliance focus.
