Senior Executive Regulatory Affairs

DKSH Management Ltd.; Malaysia; On-site; MYR 60,000 - 90,000; Full time

Job summary

DKSH Malaysia is seeking a Senior Executive Regulatory Affairs to ensure compliance across pharmaceutical and medical device operations under local regulatory authorities. This role drives regulatory excellence in a dynamic and evolving landscape.

The candidate will manage end-to-end submissions, translate requirements into practical plans, and lead process improvements across Regulatory Affairs and QA. Strong communication and analytical skills are essential for success in this role.

Qualifications

• Degree in Pharmacy or equivalent Pharmacist qualification.
• At least two years of experience in a similar Regulatory Affairs role.
• Technical expertise in the pharmaceutical industry and understanding of regulatory frameworks.

Responsibilities

• Manage end-to-end regulatory submissions — INDs, CTAs, amendments, safety reports, DSURs, and annual reports — in full regulatory compliance.
• Translate requirements into submission plans, develop timelines, coordinate authoring, review, adjudication, and archival.
• Provide input during regulatory document reviews aligning with current guidance and requirements.
• Lead local process improvements to strengthen Regulatory Affairs and QA collaborations.
• Monitor and communicate evolving international regulatory requirements to keep the organization informed.
• Manage relationships with external regulatory authorities during preparation, compilation, finalization, submission and posting of dossiers.
• Serve as liaison between Regulatory Affairs and cross-functional teams including Business Development, Quality Assurance, Supply Chain Management, and Client Management.
• Track progress toward fulfilling regulatory commitments and ensure on-time delivery.
• Author and review SOPs to ensure ongoing regulatory compliance.

Skills

Regulatory submissions management

Regulatory guidance understanding

Cross-functional collaboration

Communication skills

Analytical thinking

Education

Pharmacy degree

Job description

Select how often (in days) to receive an alert:

Title: Senior Executive Regulatory Affairs

Location: MY, MY

Global Business Unit: HEALTHCARE

Job Function: Regulatory Services

Requisition Number: 246817

Description:

About the Role

The Senior Executive, Regulatory Affairs is a pivotal contributor to DKSH's Healthcare (HEC) Business Unit, ensuring that the company's pharmaceutical and medical device operations remain fully compliant with local regulatory authority requirements. This role drives regulatory excellence across the organization, enabling the business to operate with confidence and integrity in a dynamic and evolving regulatory landscape.

What You Will Deliver

• Manage end-to-end regulatory submissions — including Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), amendments, safety reports, Development Safety Update Reports (DSURs), and annual reports — in full compliance with applicable regulations.
• Translate regulatory requirements into practical, workable submission plans; develop and maintain submission timelines; and coordinate internal and external authoring, review, comment adjudication, and finalization through to archival.
• Deliver accurate and well-reasoned input during regulatory document reviews, ensuring alignment with current regulatory guidance and requirements.
• Lead and contribute to local process improvement initiatives that strengthen the effectiveness of Regulatory Affairs, Quality Assurance, and other impacted departments.
• Monitor, review, and communicate current and emerging international regulatory requirements and guidelines to keep the organization informed and prepared.
• Manage relationships with external regulatory authorities throughout the preparation, compilation, finalization, submission, and posting of regulatory dossiers.
• Serve as the key liaison between Regulatory Affairs and cross-functional teams including Business Development, Quality Assurance, Supply Chain Management, and Client Management.
• Monitor and track the organization's progress toward fulfilling regulatory commitments, ensuring accountability and on-time delivery.
• Author and review Standard Operating Procedures (SOPs) to ensure ongoing compliance with current regulatory requirements.

What You Bring

• Degree in Pharmacy or equivalent Pharmacist qualification.
• At least two years of experience in a similar Regulatory Affairs role.
• T echnical expertise in the pharmaceutical industry, with a solid understanding of regulatory frameworks and compliance requirements.
• Excellent communication and interpersonal skills to engage effectively with internal teams and external regulatory stakeholders.
• Strong analytical and conceptual capabilities to assess and navigate complex regulatory landscapes.
• Confident and articulate, with the ability to build and sustain strong relationships across diverse stakeholder groups.
• Strong people and change leadership skills that support effective cross-functional collaboration.

Why Join DKSH

At DKSH, we help companies grow in Asia and enable people to perform at their best. You will be part of an organization that values accountability, collaboration, and long-term partnerships. We offer a dynamic environment where your contributions are visible and where you can build a meaningful career in Regulatory Affairs.