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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.