APAC Regulatory Affairs Manager

Job Title: APAC Regulatory Affairs Manager

Location: Malaysia (APAC coverage)

Overview

We are seeking an experienced APAC Regulatory Affairs Manager to lead and coordinate regulatory activities across the Asia-Pacific region, with this role based in Malaysia. This position is responsible for ensuring regulatory compliance, supporting product registrations and life-cycle management, and partnering with cross-functional teams to deliver timely regulatory submissions and approvals.

The ideal candidate will have strong regulatory expertise, excellent stakeholder management skills, and the ability to manage multiple priorities across several APAC markets.

Key Responsibilities

• APAC Regulatory Strategy:
  Own regional regulatory plans aligned with business priorities across assigned APAC markets.

• Regulatory Submissions & Life-Cycle Management:
  Manage and oversee the preparation, review, and submission of regulatory dossiers, including initial registrations, renewals, variations, and amendments as applicable.

• Compliance & Quality Oversight:
  Ensure regulatory activities follow applicable regulatory requirements, internal standards, and document control best practices.

• Regulatory Intelligence & Monitoring:
  Track changes in regulations, guidance, and country-specific requirements across APAC; assess impact and recommend actions.

• Cross-Functional Collaboration:
  Partner with R&D/Technical, Quality, Clinical/Medical (as applicable), Supply Chain, and Commercial teams to ensure submissions are aligned and timelines are met.

• Vendor & Stakeholder Management:
  Coordinate with external consultants/partners (e.g., local regulatory consultants, license holders, distributors) and manage outputs to meet expectations.

• CRO/Partner Coordination (if applicable):
  Support coordination of regulatory-related deliverables from third parties (as relevant to the product lifecycle).

• Regulatory Documentation & Audit Support:
  Maintain accurate regulatory documentation and support internal/external audits or regulatory inspections when required.

• Operational Planning & Timelines:
  Drive submission planning, milestone tracking, and effective internal communication to ensure on-time regulatory deliverables.

Qualifications

• Experience:
  Typically 8+ years in regulatory affairs within healthcare, life sciences, or related regulated industries, including experience covering multiple APAC countries (or regional oversight).

• Regulatory Knowledge:
  Strong knowledge of registration/variation processes and regulatory requirements across relevant APAC jurisdictions.

• Leadership & Stakeholder Management:
  Proven ability to lead cross-functional initiatives, manage external partners, and influence senior stakeholders.

• Project Management:
  Strong ability to manage complex regulatory timelines, prioritise effectively, and ensure high-quality submission packages.

• Communication Skills:
  Excellent communication skills in English (written and verbal). Additional local language capability is a plus.

• Education:
  Degree in Pharmacy, Life Sciences, Medical/Science, or a related discipline (advanced degree preferred).

• Industry Fit:
  Experience with highly regulated products and regulatory compliance in APAC is preferred.

Why Join This Organization?

This is an opportunity to lead regulatory excellence across APAC, enabling business growth through strong compliance and timely product lifecycle execution. If you are a regulatory leader who enjoys driving strategy, managing complexity, and partnering across teams, we invite you to apply.