Regulatory Affairs Specialist

Overview

Responsibilities

• Assist the RA director to review and submit regulatory dossiers for product registration, renewals, or variations to the relevant regulatory authorities.
• Respond to deficiency letters and additional requirements issued by regulatory authorities. Maintain close communication and collaboration with the Headquarters Regulatory Affairs Department to request and compile the necessary technical and administrative documentation.
• Assist the RA director to prepare , submit, and renew GMP certification applications. Provide in-person support at the manufacturing plant during inspections when required.
• Translate notification letters, certificates, and other relevant documents issued by regulatory authorities into English when required.
• Manage regulatory databases and monitor the internal progress of submissions. Provide monthly updates to Headquarters Regulatory Affairs Department on regulatory activities and milestones.
• Follow up in person or virtually with regulatory authorities to request information or accelerate approval procedures.
• Effectively coordinate with internal departments—including Commercial and Pharmacovigilance Department, including to respond to inquiries regarding local legislation and regulatory authority expectations.
• Review and update product artwork and inserts to ensure compliance with local regulatory requirements.
• Experience with ISP batch release procedure is a plus.

Background and Qualifications

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