Regulatory Affairs Manager

The Company

iNova is a different kind of health company. We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across Asia, Australia, New Zealand, Middle East & Africa and Europe. Experience the iNova difference today.

The Opportunity

We currently have an opportunity for Regulatory Affairs Manager to join our iNova Thailand team on a full-time basis.

Direct reporting to Country Head, Thailand and Indirect reporting to Regulatory Affairs Associate Director, Asia to lead and manage regulatory affairs activities for Thailand across product registration, lifecycle maintenance and regulatory compliance, ensuring business continuity and timely market access. The role partners closely with Country leadership and Regional/Group Regulatory Affairs (RA) to deliver compliant submissions, support promotional/medical compliance activities and coordinate quality/GxP interfaces with regional functions and local third parties (e.g., distributors, consultants, contract service providers).

Key accountabilities and performance indicators include:

1.  Perform Regulatory Activities

• Own end-to-end regulatory submissions and approvals for Thailand (new registrations, variations, renewals, transfers), including technical dossier strategy and planning, dossier compilation, e-submission and coordination of outsourced publishing (where applicable) and health authority query responses.
• Maintain licence/registration compliance (product information/labels, conditions of approval, post-approval commitments, local agent/distributor obligations, GMP Clearances) and ensure accurate maintenance of regulatory trackers and document repositories.
• Provide practical regulatory strategy and risk assessment for Thailand to support portfolio decisions, launch plans and lifecycle changes; align priorities and timelines with the Country and Regional/Group RA plans.
• Monitor and interpret Thailand regulatory changes and communicate impact to stakeholders; implement mitigation plans and support regulatory intelligence reporting.
• Maintain effective working relationships with Thailand FDA and relevant industry bodies; manage and oversee local external partners (consultants, distributors) to ensure compliant, high-quality regulatory outputs.

2. Perform Medical Affairs Activities

• Review promotional materials and external communications (HCPs, customers, consumers) for regulatory and medical compliance with local requirements and applicable industry codes; coordinate advertisement/communication approvals and permits where required.
• Coordinate pharmacovigilance interfaces for Thailand (AE/ADR reporting readiness, local requirements, internal SOP adherence) and support the management of product complaints/medical enquiries in collaboration with relevant functions.

3. Perform Quality Assurance Activities

• Interface with Regional QA and relevant functions to ensure quality and GxP requirements applicable to Thailand market activities are understood and implemented; escalate quality risks/issues and support timely resolution.
• Coordinate local inputs for quality-related activities (e.g., distributor/third-party oversight where applicable, training completion, local records readiness) in alignment with Regional QA procedures.
• Coordinate review/approval of product labels/artworks and local pack components for production, ensuring regulatory compliance and alignment to approved product information.
• Change control implementation impacting Thailand registrations (e.g., supplier/site/technical changes) by coordinating local assessments and required regulatory submissions with Regional QA/Technical Operations/Supply Chain.

To be successful in this role, you will possess the following

• 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), including proven experience managing registrations, variations and renewals, including direct face to face interactions, regulatory discussions, and negotiation with Thailand FDA reviewers.
• Working knowledge of Thai requirements for labelling, product information and advertising/communication approvals/permits (as applicable to the portfolio).
• Experience coordinating cross-functional stakeholders (Commercial, Supply Chain, QA, PV, Technical Operations) and managing external parties (consultants/distributors) to deliver submissions and maintain compliance.
• Strong working knowledge of regulatory systems, document management and tracking tools; able to maintain inspection-ready records and dashboards/metrics.
• Fluent in Thai and English (written and spoken), with strong technical writing and stakeholder communication skills.

Additional Requirements / Working Conditions

• Adhere to company values at all times

If you wish to be part of an energetic team within a thriving organisation, focused on bringing innovative products to market, please APPLY TODAY! We want you to join us in our pursuit of healthy living!