Senior Regulatory Affairs Leader – Pharma & Med Devices

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

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