Senior Regulatory Specialist

Company: Torrent Pharma (Thailand) Co, Ltd

Job title – Assistant Regulatory Manager/ Senior Regulatory Specialist

Location: Bangkok, Thailand

Workplace: On-site

Category:  Healthcare & Medical 
• Pharmaceuticals & Medical Devices

Work type: Full-time

Experience Required: 1–3 Years

Company Profile

Torrent Pharma :-Torrent Pharma, the flagship company of the Torrent Group, boasts a substantial market capitalization exceeding $12 billion USD. With over half a century of dedicated service, Torrent has emerged as a prominent player in the global pharmaceutical landscape. Our expertise shines particularly in therapeutic segments encompassing cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI), and women's healthcare (WHC). Our competitive edge is deeply rooted in state-of-the-art manufacturing facilities that have earned approvals from globally esteemed regulatory authorities such as the US, EU, TGA (Australia), MHRA (UK), TH FDA, and many more. Present in over 50 countries, we have strategically segmented Torrent Pharma's international business across the United States, the United Kingdom, Germany, Europe, Brazil, and emerging markets to foster strategic differentiation.

Torrent Pharma, a pioneer in the introduction of Neurology, Psychiatric and cardiology medications in over 50 countries, is now extending its commitment to Quality and Affordability to the healthcare landscape of Thailand. With our fundamental principle of "1 Product - 1 Globe - 1 Quality," we are dedicated to providing not only medicines but also building stronger relationships with the medical community.

At Torrent, every employee is entrusted with challenging, interesting, and motivating assignments that make them think out of the box. Holistic development of our employees is of prime importance for us. We create an encouraging and conducive work environment for the employees that keeps the zeal to perform alive.

About the Role:

We are looking for a skilled and motivated Regulatory Affairs Manager to lead and oversee all regulatory operations for our pharmaceutical business in Thailand. The ideal candidate will ensure end-to-end compliance with Thai FDA regulations while aligning with global regulatory standards. This is a critical role contributing to product lifecycle management, market access, and operational excellence across our regulatory function.

Key Responsibilities:

• Lead and manage all regulatory submissions including product registrations, renewals, and variations in line with Thai FDA requirements.
• Handle GMP submissions, GDP compliance, IL applications/renewals, and regular authority reporting.
• Coordinate with Contract Research Organizations (CROs) for Bioequivalence (BE) studies.
• Evaluate new products and provide strategic regulatory inputs for filing plans.
• Ensure up-to-date compliance with evolving local regulatory frameworks.
• Collaborate cross-functionally with R&D, QA, Marketing, and Supply Chain teams.
• Ensure documentation accuracy and data integrity in all regulatory dossiers.
• Support commercial teams with tenders, labeling, and compliance-related requirements.
• Provide regulatory guidance to internal teams and resolve queries efficiently.

Qualifications & Skills:

• Bachelor's degree or higher in Pharmacy, Life Sciences, or related field.
• 1–3 years of hands-on experience in Regulatory Affairs within the Thailand pharmaceutical industry.
• In-depth knowledge of Thai FDA procedures, product registration systems, and e-submission platforms.
• Strong coordination, documentation, and communication skills.
• Experience with both Rx (prescription) and OTC (over-the-counter) pharmaceutical products is an advantage.
• Ability to work independently while also supporting cross-functional teamwork.

Why Join Us?

• To be a part of Global Organization
• Playing role as a leader and be part of aggressive expansion strategy of Company in Thailand
• Independently work to manage regulatory tasks
• Opportunity to lead regulatory strategy and shape product success.
• Competitive salary and comprehensive benefits.

How to Apply:

Interested candidates can send their CV and cover letter to the subject line: Application – Assistant Regulatory Manager/ Senior Regulatory Specialist