Pathnsitu Biotechnologies | Hyderabad
Experience: 1–2 Years | Job Type: Full time
Job Summary
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.