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 outsourcing activities.

Support and monitor ...