Regulatory Affairs Supervisor/ Section Manager

MAJOR TASKS:

• 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

Responsible in all aspect of functions relating to Ministry of Public Health for the manufacturing and repackaging of company drugs and healthcare items such that the company obtains the approval in timely manner and is in compliance to the Regulatory Act in all aspect. Coordinate with FDA to achieve company required target.

DUTIES & RESPONSIBILITIES:

LICENSES

• To process for all MOPH related Licenses in timely manner.
• To coordinate for the renewal and updating of Licenses.

PRODUCT REGISTRATION

• 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.

CONTROLLED SUBSTANCE

• 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

PLANT DESIGN

To coordinate with authority for the approval and inspection of plant design layout change/ or improvement.

EXPORTATION / IMPORTATION

• To prepare necessary technical file for Export or Import Registration.
• To arrange to have required Regulatory documents for Export or Import

REPORT

• 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.

MISCELLANEOUS

• 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.

Qualifications:

• Bachelor degree in Pharmacy
• 5-10 years experience in RA-manufacturing of Pharma/Food industry

Benefits

• Five-day work week
• Performance bonus
• Insurance
• Provident fund
• Near BTS Sena Nikhom