Regulatory Affairs Executive - Walk-in Opportunity

Role Overview

Pharmazone invites applications for the position of Regulatory Affairs Executive to support their regulatory affairs team. This role demands efficient project timeline management and execution, ensuring seamless coordination throughout all stages of regulatory documentation and submission.

Key Responsibilities

• Assist the senior regulatory affairs team with project execution and delivery deadlines.
• Manage and maintain all documentation associated with the regulatory affairs department.
• Conduct thorough technical document reviews of client-submitted product materials intended for registration.
• Identify document and data gaps required for dossier compilation through detailed gap analysis.
• Draft and critically review dossiers covering drug substances, drug products, and administrative components.
• Continuously update and maintain an up-to-date knowledge database of regulatory guidelines.
• Collaborate effectively with cross-functional teams to ensure compliance with regulatory demands during dossier submission and throughout product life cycles.
• Prepare and assess responses to deficiency letters received from health regulatory authorities during marketing authorization and drug registration evaluations.
• Manage regulatory submission processes for US (ANDA), European, and other Rest of World markets.