Regulatory Affairs – Clinical Operations

The role involves managing regulatory documentation, supporting regulatory submissions, and ensuring compliance with applicable guidelines and requirements within the pharmaceutical and clinical research industry. The candidate will coordinate with internal teams and regulatory authorities to support approvals, maintain accurate records, and ensure regulatory activities are completed within established timelines.

Qualifications

• Prepare, review, and maintain regulatory documents and submission records.
• Support regulatory submissions, product registrations, renewals, and amendments, as applicable.
• Ensure compliance with relevant regulatory guidelines, requirements, and company SOPs.
• Coordinate with internal teams to collect and verify documentation required for submissions.
• Monitor regulatory updates and communicate changes to relevant stakeholders.
• Maintain regulatory trackers, databases, and documentation for audits and inspections.
• Support responses to regulatory queries and follow up on pending approvals.
• Ensure accuracy, completeness, and timely submission of regulatory documents.
• Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Clinical Research, or a related field.
• Relevant experience in Regulatory Affairs within the pharmaceutical, healthcare, or clinical research industry.
• Knowledge of regulatory guidelines, documentation, and submission processes.
• Strong written communication, coordination, and documentation skills.
• Proficiency in MS Office and the ability to manage multiple tasks and deadlines.