OVERVIEW OF THE JOB

You will be one of our key drivers behind our continued growth and success. With our commitment, it’s you who will seek out, develop, and help to perform our regulatory-related activity efficiency and productivity.

To get the job done, you need to be a detailed planner, well communicator and analyst to understand and work well with Thai FDA authority (Food and Drug Administration) and external customers/distributors, etc

You will also be our company pharmacist responsible for the activity related to the Medicinal importation and selling license we owned as required by local law and shall work with another team

YOUR TEAM

You will report to the Head of PHC Regulatory Affairs who is based in Bangkok. Working in the Personal Health Care (PHC) regulatory affairs team in P&G, specifically for Thailand Territory, you will be part of a winning team that is both business leaders and technical masters. We do this through innovative and working in one team with our consumer health business and contemporary technologies and capabilities

HOW SUCCESS LOOKS LIKE

• You have the ability to understand regulatory requirements and regulations related to product registration in a more intimate level so that you can provide opinions and advise a deeper conversation with the authority and/or regional team.
• Lead and drive working plan independently and provide result/response within the timeline
• Support business by given consultation of technical aspect which leads to changes and, where needed, driving the country regulatory requirements changes to be aligned with international requirements as much as possible

RESPONSIBILITIES

• Author and update internal and external documentation/requirements and to deliver improve regulatory effectiveness and troubleshoot problems in the registration of New products for TH PHC portfolio as planned/appropriate.
• Partner with team members (i.e. RA, QA, Marketing, Supply chain, etc) to manage the product to be valid with compliance to local regulation (i.e. variation/renewal/GMP clearance submission and approval)
• Submit for Promotional material approvals (FDA)
• Prepare TH FDA reports related to Medicinal and non-medicinal products as required by local regulation
• Update RA (Regulatory Affairs) database in company system on a continuing basis, and maintain systems processes, including the delivery of monthly status reports to team lead
• Approve responsible artwork for internal activities
• Support Purchase order (PO) approval for RA related activities and other special regulatory projects such as company license application approval and renewal of the license, Marketing authorization transfer (MAT)
• Develop meaningful and positive relationships with partners for optimized the product registration

Qualifications

• Bachelor’s in Pharmaceutical Science, prefer in pharmaceutical technology subject with an excellent academic background.
• Experience in registration products under the Thai FDA responsibility including Medicines, Cosmetics, Food supplements is preferred or with proven of highly proficient technical knowledge/capabilities.
• Born leaders and are passionate to make things happen.
• Have strong analytical thinking and skills.
• Proficient in English and Thai.
• Thai Nationality.
• Hold a valid Pharmacist license