Regulatory Affairs Officer - บริษัท โอลิค (ประเทศไทย) จำกัด

• Prepare and manage the physical file of registration documents including an update for any variations of products.

• Manage dossiers and GP document destruction process.

• Prepare, coordinate and submit for import permission with Thai FDA.

• Prepare, coordinate and manage for all licenses of the company to ensure the validity of licenses at all times.

• Prepare, coordinate and renew Thai FDA's authorization document for company team members to ensure that the relevant departments are able to access FDA system to perform their activities and meet FDA's requirements.

• Prepare for annual and 4-month report to Thai FDA according to the regulation.

• Check, verify the packaging materials artworks compare with the approval artworks from FDA.

• Prepare, manage, check and coordinate for the RA expense reimbursement requests.

• Prepare, manage, coordinate and travel to consular and embassy to obtain certified document, including regularly contact with existing or new embassy and to keep the team updated of any changes of requirements.

• Prepare the company's forms and manage the GP documents according to the company's internal SOP/WI.

• Any other assigned administrative tasks.

• Bachelor Degree in any field

• 0-2 years of experience

• Good command of English and computer literacy

• Excellent attention to details

• Effective communication, inter-personal skills, problem solving and dicision making

Toll and contract manufacturer of choice for Global Pharmaceutical, Healthcare and Personal Care companies.

OLIC has cultivated successful partnerships that last.

The company is a trusted partner of more than 30 multinational companies, including most of the Big Pharma organizations. The OLIC Manufacturing facility complies to GMP requirements to the PIC/S guide for Good Manufacturing Practice for Medicinal products. Products made by OLIC are serving not only markets in Thailand and South-East Asia, but also Japan, Australia, US, and Europe.