Regulatory Affairs Analyst

The 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 & Responsibilities

• Prepare, 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 & Experience

• Minimum 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.
• Experience in formulations (finished dosgages) is mandatory/compuslory