Regulatory Affairs Assistant Manager

OLIC (Thailand) Limited (Phra Nakhon Si Ayutthaya)

Ayutthaya, Thailand

OLIC has cultivated successful relationships that last. The company is a trusted partner to over 30 multinational companies, including most of the Big Pharma organizations. The OLIC manufacturing facility complies with GMP requirements following the PIC/S guide to Good Manufacturing Practice for Medicinal Products. Products made by OLIC serve not only the markets in Thailand and Southeast Asia, but also Japan, Australia, the US and Europe.

Detail posisi

The Regulatory Affairs Assistant Manager is responsible for overseeing regulatory submissions, compliance monitoring, and documentation management to ensure that the company's products meet all regulatory requirements.

Kewajiban

• Prepare and submit regulatory documents to the Thai Food and Drug Administration (TFDA) for product registration, variations, and renewals.
• Registration of new products as plan to ensure the launch plan for products portfolio will be as scheduled.
• Responsible for product license renewal, company's license, GMP clearance, amendment and annual report.
• Maintain the registration license up to date throughout the lifecycle of products as required by local regulations.
• Monitor changes in regulatory requirements and ensure company policies and practices remain compliant.
• Conduct internal audits and training programs to ensure adherence to regulatory standards across departments.
• Maintain and manage regulatory files and databases, ensuring all documents are current and accessible.
• Prepare and review labeling and promotional materials for compliance with regulatory standards.
• Coordinate all related responsibilities for Bioavailability(BA)/ Bioequivalent(BE), Clinical study center and regulatory authority.
• Pharmacovigilance coordinator to improve public health and safety in relation to the use of pharmaceutical products.

Kualifikasi

• Bachelor's degree in Pharmaceutical Sciences.
• At least 5-8 years experience in Regulatory Affairs responsible for Pharmaceutical products.
• In-depth knowledge of Thai regulatory processes and international standards.
• Strong analytical, organizational, and project management skills.
• Excellent communication skills in both Thai and English.