Job Description
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.
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 St...