Production Regulatory Specialist

Job Description

• Prepare CTD dossier for the locally manufactured products.
• Cooperate in obtaining the HA approvals for the new APIs, excipients, and finished products.
• Maintain the registration licenses for the APIs, excipients, and finished products and preparation of all the relevant regulatory submissions.
• Make effective follow-ups with the HA on the open issues.
• Handle all the assigned tasks for the PMQC.
• Prepare bilingual artwork (outer box, leaflet).
• Review all the relevant documents for the locally manufactured products in compliance with the applicable regulations.
• Take all the necessary actions for the product release (document review, data logger handling, etc.)
• Perform all the assigned tasks on TTAC (customs clearance for the APIs, finished product release, etc.).
• Perform all the assigned tasks for the product sampling, including reference material registration.
• Handle customer complaints.
• Handle all the assigned tasks for the destruction process.
• Cooperate in regulatory inspections (HA, partners).

Requirements:

• PharmD; Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biology or similar fields.
• At least 3 years of experience in regulatory in the pharmaceutical industry.
• Effective time management skills, and ability to handle multiple projects and tasks simultaneously.
• Fluent in English.
• Excellent organization skills and attention to detail.
• Excellent skills in Microsoft Office.