Senior Executive Regulatory Affairs

DKSH Group; Petaling Jaya; On-site; MYR 120,000 - 180,000; Full time

Job summary

DKSH in Malaysia is seeking a Senior Executive, Regulatory Affairs to ensure pharmaceutical and medical device operations comply with local authorities. This pivotal role drives regulatory excellence across the HEC unit and partners with cross-functional teams to maintain integrity in a dynamic regulatory landscape.

You will manage end-to-end submissions, translate requirements into submission plans, monitor global guidelines, and draft SOPs while building strong relationships with authorities

Qualifications

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

Responsibilities

• Manage end-to-end regulatory submissions — including INDs, CTAs, amendments, safety reports, DSURs, and annual reports — in full compliance with applicable regulations.
• Translate regulatory requirements into practical, workable submission plans; develop and maintain submission timelines; coordinate authoring, review, comment adjudication, and finalization through to archival.
• Deliver input during regulatory document reviews, ensuring alignment with current regulatory guidance and requirements.
• Lead and contribute to local process improvement initiatives that strengthen regulatory affairs, QA, and other impacted departments.
• Monitor and communicate current and emerging international regulatory requirements and guidelines.
• Manage relationships with external regulatory authorities throughout preparation, compilation, finalization, submission, and posting of regulatory dossiers.
• Serve as liaison between Regulatory Affairs and cross-functional teams including Business Development, QA, Supply Chain, and Client Management.
• Monitor and track progress toward fulfilling regulatory commitments, ensuring accountability and on-time delivery.
• Author and review SOPs to ensure ongoing compliance with current regulatory requirements.

Skills

Regulatory knowledge

Regulatory submissions

Cross-functional collaboration

Communication skills

Analytical thinking

Leadership

Education

Degree in Pharmacy or equivalent Pharmacist qualification

Job description

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Title: Senior Executive Regulatory Affairs

Location: Petaling Jaya, MY, MY

Global Business Unit: HEC

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.