Senior Executive Regulatory Affairs

DKSH Malaysia Sdn Bhd; Selangor; On-site; MYR 67,000 - 134,000; Full time

Job summary

DKSH Malaysia Sdn Bhd in Selangor seeks a Senior Executive, Regulatory Affairs to ensure pharmaceutical and medical device operations comply with local regulators. This role drives regulatory excellence across the organization, enabling the business to operate with confidence and integrity in a dynamic regulatory landscape.

You will manage end-to-end regulatory submissions, translate requirements into workable submission plans, provide input during document reviews, and lead process

Qualifications

• Degree in Pharmacy or equivalent Pharmacist qualification.
• At least two years of experience in Regulatory Affairs.
• Technical expertise in pharmaceutical regulatory frameworks and compliance.
• Excellent communication and interpersonal skills with internal and external stakeholders.
• Strong analytical and conceptual capabilities for navigating regulatory landscapes.
• Confident, articulate, and able to build cross-functional relationships.

Responsibilities

• Manage end-to-end regulatory submissions including INDs, CTAs, amendments, DSURs and annual reports.
• Translate regulations into practical submission plans and maintain timelines.
• Provide accurate input during regulatory document reviews and ensure alignment with guidance.
• Lead local process improvements to strengthen Regulatory Affairs and QA integration.
• Monitor and communicate current and emerging regulatory requirements.
• Manage relationships with external regulatory authorities and dossier submissions.
• Serve as liaison between Regulatory Affairs and cross-functional teams.
• Track progress toward regulatory commitments and ensure on-time delivery.
• Author and review SOPs to maintain ongoing compliance.

Skills

Regulatory submissions

Regulatory strategy

Stakeholder communication

Process improvement

Regulatory intelligence

SOP writing

Cross-functional collaboration

Regulatory liaison

Education

Degree in Pharmacy or Pharmacist qualification

Job description

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.
• Technical 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.

DKSH's purpose is to enrich people's lives. For nearly 160 years, we have been marketing, selling, and distributing high-quality products and brands for multinational and Fortune 500 companies. Through our Business Units Consumer Goods, Healthcare, Performance Materials, and Technology, we deliver sustainable growth for our partners. We contribute to improving the quality of life for our employees and people in the local communities in which we operate. Headquartered in Switzerland, DKSH is publicly listed and operates in 36 markets across Asia Pacific, Europe, and North America. We employ over 29,000 specialists and produced net sales of CHF 11.1 billion in 2023.

DKSH's purpose is to enrich people's lives. For nearly 160 years, we have been marketing, selling, and distributing high-quality products and brands for multinational and Fortune 500 companies. Through our Business Units Consumer Goods, Healthcare, Performance Materials, and Technology, we deliver sustainable growth for our partners. We contribute to improving the quality of life for our employees and people in the local communities in which we operate. Headquartered in Switzerland, DKSH is publicly listed and operates in 36 markets across Asia Pacific, Europe, and North America. We employ over 29,000 specialists and produced net sales of CHF 11.1 billion in 2023.