Operation

• Implementing on getting required product license for drug
• Arrangement on renewal registration in time without impact on business
• Consultation with clients and internal teams on regulatory process with requirements
• Arrangement on importation of drug sample, DIAC, one time permit and lot release for commercial 
• Following up with local authority for ongoing process and pending issue if required
• Preparing and submission of financial advances and claims internally and externally

Reporting

• Submission of daily report for registration activity of respective clients to immediate supervisor
• Submission of status reporting and discussion with client on registration process and requirement
• Updating regulatory submission and achievement monthly

Management

• Reviewing and management on Regulatory process and system
• Archiving the documents and inventory in good documentation practice

Coordination

• Informing the external clients and internal depts. about update procedure, guideline or regulation
• Implementing on appointment and hosting local authority for meeting or inspection
• Cooperation in internal and external audit related to RA and PV with CAPA
• Advising on importation, storage and distribution process based on existing regulation and guideline
• Acting as liaison between client and government authority in RA and PV issue
• Align with BD, Client Management, ISC, Sales and Marketing, logistic etc. for purchase order, importation and stock balance.

• Any Bachelor Degree holder in Science, preferably B.Pharm.
• Prefer 1-2 years experience in related field and fresher also welcome. 
• Computer literacy, Microsoft excel & Mail Accounting knowledge.
• Honest and work hard, Strong communication with different function.
• Strong interpersonal, negotiation and communication skills.