Regulatory Affairs - บริษัท ออพติมา อินเตอร์เนชั่นแนล จำกัด
บริษัท ออพติมา อินเตอร์เนชั่นแนล จำกัด · Bangkok (Klongtoey)
- Location
- Bangkok (Klongtoey)
- Salary
- Depend on qualifications and experience
- Job Type
- Full Time
- Work Type
- Onsite
- Education
- Bachelor's Degree
- Posted
- 06/05/2026
Responsibilities
• Ensuring consistency, completeness and adherence to standards for all regulatory submissions
• Maintain up-to-date knowledge on international and domestic regulatory requirements
• Perform regulatory affairs activities ensuring compliance with FDA and other regulatory agencies including but not limited to
• Liaising with FDA to monitor the progress of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay
• Monitor and interpret regulations to evaluate the impact on the business
• Ensures compliance with local regulatory requirements
• Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
• Execute assigned regulatory tasks for medical devices, manufacturing, or labeling changes
• Manages process for case analytics and implements new medthodologies to identify patterns and trends concerning important regulatory topics
• Oversees the development and expansion of regulatory contact database
• Must be goal oriented, able to work within cross-functional team environment, self-motivated and understand the business needs to meet the timelines
• Ensuring regulatory strategy is in alignment with company objectives
• Support the regulatory team managing international and domestic filings/registrations
• Provide regulatory support to the CMO/OEM deployment group
• Participate in regular team and group meeting to keep management team updated on issues and actions which impact the business
Qualifications
• Thai Nationality
• Bachelor's degree in Pharmaceutical Science
• 3 -10+ years’ experience in regulatory affairs of pharmaceutical and medical devices
• Actively responsible, well-organized and able to work independently as well as a part of a team Ability to manage priorities under pressure and be able to multi-tasks
• Multitasking, interpersonal and willing to learn with good attitudes Good analytical, influencing and communication skills
• Good command in English both writing and speaking and computer literacy
Benefits
- Directly to BTS Nana skywalk
- Opportunity to traveling aboard to attend conferences
- 5-day work week
- Social security
- Annual bonus
About บริษัท ออพติมา อินเตอร์เนชั่นแนล จำกัด
Optima International is dedicated to establishing itself as a leading regional hub for ophthalmic pharmaceuticals and medical devices, addressing the significant unmet medical needs in Thailand and across Southeast Asia.
As we expand our collaborations with both existing and prospective partners across Thailand and key international markets—including Singapore, Malaysia, Indonesia, Vietnam, South Korea, Taiwan, Australia, and New Zealand—we are positioning ourselves to capture not only the growing ophthalmology opportunity in Thailand but also the significant potential across the broader region.
Our growing company is currently seeking experienced candidates for the Regulatory Affairs position. If you are interested in joining a dynamic and ambitious workplace, please take a moment to review the qualifications listed below.
While this outlines our ideal qualifications, we remain open to candidates who may not meet every criterion but demonstrate strong relevant experience and potential.
As we expand our collaborations with both existing and prospective partners across Thailand and key international markets—including Singapore, Malaysia, Indonesia, Vietnam, South Korea, Taiwan, Australia, and New Zealand—we are positioning ourselves to capture not only the growing ophthalmology opportunity in Thailand but also the significant potential across the broader region.
Our growing company is currently seeking experienced candidates for the Regulatory Affairs position. If you are interested in joining a dynamic and ambitious workplace, please take a moment to review the qualifications listed below.
While this outlines our ideal qualifications, we remain open to candidates who may not meet every criterion but demonstrate strong relevant experience and potential.
6 อาคารโอเนสทาวเวอร์ ชั้น 6 ซอยสุขุมวิท 6 แขวงคลองเตย เขตคลองเตย กรุงเทพมหานคร 10110
มณีรัตน์
089-812-7176