Regulatory affairs analyst
Há 4 dias
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 submithigh-quality CTD dossiersfor new drug product registrations and post-marketing variations in compliance with regulatory requirements.Prepare and respond toDeficiency Letters issued by ANVISA, ensuring timely and accurate submissions.Conductrisk assessments and gap analysesto enhance regulatory processes and improve dossier quality.Develop and implement regulatory strategies forPharmaceutical Equivalence Studies and Biowaivers, including coordination of outsourcing activities.Support and monitor theimportation processin line with regulatory compliance requirements.Evaluate regulatory feasibility and identify potential risks or requirements to support project execution.Qualifications & ExperienceMinimum5 years of experiencein Regulatory Affairs or Technical Documentation within thepharmaceutical industry.Bachelor's degree or higherin Pharmacy, Chemistry, Biology, Biomedicine, or a related field.Strong working knowledge ofANVISA regulations, as well as international regulatory guidelines and processes.Proven ability to manage regulatory documentation with accuracy, attention to detail, and compliance focus.
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