Senior Executive Regulatory Affairs

DKSH; Petaling Jaya; On-site; MYR 78,000 - 112,000; Full time

Job summary

DKSH in Malaysia seeks a Senior Executive, Regulatory Affairs to ensure pharmaceutical and medical device operations stay compliant with local regulatory requirements. The 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, coordinate timelines, and liaise with cross-functional teams to ensure on-time delivery and archival of dossiers.

Qualifications

• Pharmacy degree required or equivalent Pharmacist qualification.
• Minimum 2 years of experience in Regulatory Affairs.
• Solid understanding of regulatory frameworks and compliance requirements.
• Excellent communication and interpersonal skills.
• Strong analytical and conceptual capabilities.
• Proven ability to lead cross-functional collaboration.
• Ability to build relationships with diverse stakeholder groups.

Responsibilities

• Manage end-to-end regulatory submissions including INDs, CTAs, amendments, safety reports, DSURs, and annual reports.
• Translate regulatory requirements into submission plans and maintain timelines.
• Provide input during regulatory document reviews aligned with current guidance.
• Lead local process improvement initiatives in Regulatory Affairs and related departments.
• Monitor international regulatory requirements to keep the organization informed.
• Manage relationships with external regulatory authorities for dossiers.
• 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 ensure ongoing compliance.

Skills

Regulatory submissions

Regulatory compliance

Stakeholder management

Regulatory intelligence

Communication

Analytical thinking

Education

Pharmacy degree

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.