Regulatory Affairs Manager

iNova Pharmaceuticals

Regulatory Affairs Manager for iNova leading regulatory affairs and compliance activities in Thailand. Owning end-to-end submissions and ensuring compliance with local regulatory requirements.

Posted 5/17/2026full-timeBangrak • 🇹🇭 ThailandSeniorLeadWebsite

About the role

Key responsibilities & impact

Own end-to-end regulatory submissions and approvals for Thailand
Maintain licence/registration compliance and ensure accurate maintenance of regulatory trackers
Provide practical regulatory strategy and risk assessment for Thailand
Monitor and interpret Thailand regulatory changes and communicate impact to stakeholders
Maintain effective working relationships with Thailand FDA and relevant industry bodies
Review promotional materials and external communications for regulatory and medical compliance
Coordinate pharmacovigilance interfaces for Thailand
Interface with Regional QA and relevant functions to ensure quality and GxP requirements are understood and implemented
Coordinate local inputs for quality-related activities

Requirements

What you’ll need

Bachelor’s degree in pharmacy (required)
Current Thai pharmacist license/registration (Pharmacy Council of Thailand) (required)
Post-graduate qualification (e.g., regulatory science, quality, life sciences) is desirable
7+ years’ experience in Regulatory Affairs within Thailand (pharmaceuticals and/or consumer health)
Working knowledge of Thai requirements for labelling, product information and advertising/communication approvals/permits
Experience coordinating cross-functional stakeholders (Commercial, Supply Chain, QA, PV, Technical Operations)
Strong working knowledge of regulatory systems, document management and tracking tools
Fluent in Thai and English (written and spoken)

Benefits

Comp & perks

Adhere to company values at all times

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsregulatory strategyrisk assessmentpharmacovigilancequality assuranceGxP requirementsregulatory compliancedocument managementlabeling requirementsadvertising approvals

Soft Skills

stakeholder communicationrelationship managementcross-functional coordinationstrategic thinkingproblem-solvingattention to detailorganizational skillsinterpersonal skillsadaptabilityteam collaboration

Certifications

Bachelor’s degree in pharmacyThai pharmacist licensepost-graduate qualification in regulatory science