Pathnsitu Biotechnologies is looking for a Junior Regulatory Affairs Associate to support regulatory documentation, product registrations, submissions, and compliance activities.
Key Responsibilities
- Prepare and maintain regulatory documents and submission dossiers.
- Support product registration, renewal, and amendment activities.
- Coordinate with R&D;, QA, QC, and other departments for regulatory documentation.
- Review documents for completeness and compliance.
- Maintain regulatory trackers and records.
- Support responses to regulatory queries and additional information requests.
- Monitor applicable regulatory guidelines and requirements.
- Ensure timely submission and proper document control.
Requirements
- Bachelor's/Master's degree in Biotechnology, Life Sciences, Microbiology, Pharmacy, Biomedical Sciences, or related field.
- 1–2 years of experience in Regulatory Affairs, with hands-on exposure to ISO 13485 requirements.
- Experience or exposure to internal/external audits and regulatory/quality audits will be an added advantage.
- Knowledge of QMS documentation, CAPA, change control, risk management, and document control is preferred.