Duangjai Chanprajuk
RA manager
Bangmot
Summary
RA manager
Regulatory Affairs professional with over 14 years of experience in pharmaceutical product registration, lifecycle management, and regulatory strategy. Strong expertise in Thai FDA, ASEAN and international regulations. Proven ability to manage regulatory submissions, coordinate cross-functional teams, and ensure timely product approvals.
Overview
20
20
years of professional experience
Work History
Associate regulatory affair manager
Thai Otsuka pharmaceutical
05.2014 - Current
- Preparation and submission of New Drug Applications (NDA) for product registration.
- Manage end-to-end product lifecycle including variation, NDA renewal, GMP clearance and renewal, and promotional materials.
- Develop regulatory strategy to support product launch and lifecycle management.
- Evaluate regulatory impact on business operations.
- Coordinate with QA, QC, PV, import, marketing and global team to support regulatory activities.
- Provide consultancy support to the marketing team for hospital tender preparation and management.
- Provide consultancy support to the marketing team for promotional materials.
- Manage and coach RA team members.
Regulatory affair officer
Siam Bheasach Co.,Ltd
01.2012 - 04.2014
- Responsibility for assigned activities pertaining to product registration, registration amendment for all product (New generic, generic).
- Handling any matters related to quality and regulatory compliance e.g., deviations, change control.
- Responsibility for labeling and artwork updates.
Kasemrad prachachuen hospital
02.2009 - 02.2011
- Dispensed prescriptions for both inpatient and outpatient.
- Clinically monitored patients and provided clinical support to physicians.
- Assists pharmacist technicians regarding filling of prescriptions, counseling patients and contacting health care.
Thai FDA (Food and Drug Administration)
01.2006 - 01.2009
- National List of Essential Medicines (NLEMs): Formulated a national drug policy (NDP) based on the concept of essential medicines.
- Secretariat of NLEM subcommittee.
- NLEM working co-operation committee (technical information reviewer and minute writing).
- Orphan drug: Pre-screen registration documents for orphan drugs and cooperate with traders to ensure successful registration.
Education
Bachelor's degree - Pharmacy
Rangsit University
pathumthani, ThailandSkills
Soft skillls
Time management with various projects
Good listening and communication skill
Problem solving and positive thinking
Hard skills
Fluent communicating in Thai and English
Microsoft office
PDF adobe
Docubrige/E-submission (Skynet)
Timeline
Associate regulatory affair manager
Thai Otsuka pharmaceutical
05.2014 - Current
Regulatory affair officer
Siam Bheasach Co.,Ltd
01.2012 - 04.2014
Kasemrad prachachuen hospital
02.2009 - 02.2011
Thai FDA (Food and Drug Administration)
01.2006 - 01.2009
Bachelor's degree - Pharmacy
Rangsit University