Senior Regulatory Affairs Lead – Pharma & Medical Devices

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

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.