Regulatory Affairs Section Manager

Interthai Pharmaceutical Manufacturing Ltd.

Interthai Pharmaceutical Manufacturing Ltd. (Chatuchak)

Chatuchak

Bangkok, Thailand

We are International Manufacturing Company having more than 500 employees in Thailand plant with more than 40 years reputation in Pharmaceutical Manufacturing Industry in Thailand and in Asia Pacific. With the requirement of our business development and our continuous growth in Thailand market as well as in Asia Pacific region, we are now searching for competent, enthusiastic and highly qualified candidates for the following challenging position:

About this position

Responsible for all aspects of functions relating to the Ministry of Public Health for the manufacturing and repackaging of company drugs and healthcare items, ensuring timely approval and compliance with the Regulatory Act.

Responsibilities

• MOPH Licenses Application, Compliance & Renewal
• Product Registration & all amendments
• Controlled Substance Permit, Compliance & Purchase
• MOPH Plant Improvement
• Technical File for Export Import & Document to support tender, custom clearance
• To process for all MOPH related Licenses in timely manner.
• To coordinate for the renewal and updating of Licenses.
• To process for product registration in timely manner.
• To ensure that technical specification and text amendments are updated in registration file.
• To review packaging artwork for text and regulatory compliance.
• To coordinate with authority for acquiring necessary permits.
• To coordinate with authority for purchasing of controlled substance.
• To coordinate with authority for witnessing the destruction of controlled substance.
• To review and submit the reports to Authority as required
• To coordinate with authority for the approval and inspection of plant design layout change/ or improvement.
• To prepare necessary technical file for Export or Import Registration.
• To arrange to have required Regulatory documents for Export or Import
• To organize the preparation of monthly / triannual / annual report to Authority.
• To organize the preparation of another report as regulation.
• To monitor monthly status report.
• To communicate effectively with other managers and customer principals for the updated status of product registration and regulatory change situation.
• To perform other duties that may be assigned by the Regulatory Affairs Department Manager/ Group Manager and Technical Operations Division Manager from time to time.

Requirements

• Bachelor degree in Pharmacy
• 7-10 years experience in RA-manufacturing of Pharma/Food industry