Reports To

Regulatory   Executive   will report to MD   and Regulatory Manager.

Job Overview

• Achieved DRCs, DIACs for pharmaceuticals, IRs and cosmetic notifications for FMCG products in FDA Cambodia.
• Handling clients of 12 both pharmaceuticals and FMCG products across 9 countries in Asia and Europe.
• Proficient in online submission for new registrations, gathering details and reviewing renewal requests.
• Expedited for dossier checking and preparation for registration.
• Managed for company registration and license application.

Responsibilities and Duties

-    Ensures compliance with all company procedures  / SOP’s and government regulations

• ensuring compliance with regulations set by Cambodia FDA
• planning, undertaking, and overseeing product trials and regulatory inspections
• keeping up to date with changes in regulatory legislation and guidelines
• offering advice about company policies, practices and systems
• outlining requirements for labelling, storage and packaging
• using a variety of specialist computer applications
• liaising and negotiating with regulatory authorities
• providing advice about regulations to manufacturers/scientists
• ensuring that quality standards are met and submissions meet strict deadlines
• preparing documentation for Registration, Import License 
• reviewing and checking the validity date of product license
• asking preapproval of registration fees from clients

• analyzing the new products approval list of FDA- Cambodia  announcement
• Every Saturday, WIP report to MD and regulatory Manager
• Keep abreast of new product launches and ensure sales team members are on board
• planning, undertaking, and overseeing product trials and regulatory inspections

Qualifications and Experience

• University Degree in Pharmaceutical Science or Science or related field
• Four or more years experienced with regulatory affairs in the medical and pharmaceutical field

• Language Skills and Other Skills

• English
• Computer Skills
• Legal Knowledge skills
• Management skills
• Administrative skills
• Communication Skills
• Strategic Planning skills
• Problem Solving skills
• Technical Skills

• Certificate, License, Others

  MS Office Suite, Adobe Photoshop CS3, Adobe PageMaker 7