Regulatory Affairs Analyst

Job Title: Regulatory Affairs (RA) Analyst

About the Position

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.

• 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 outsourci...