Kerja Sepenuh Masa, Senior Executive, Regulatory Affairs di DCH Auriga (Malaysia) Selangor - Maukerja

We Are Hiring: Regulatory Affairs Senior Executive

Shah Alam, Selangor, Malaysia

DCH Auriga (Malaysia) Sdn Bhd

About the Company

DCH Auriga (Malaysia) Sdn Bhd is a leading healthcare distribution and commercial services provider, partnering with global pharmaceutical and healthcare companies to deliver high-quality products across Malaysia.

We are committed to ensuring regulatory excellence, compliance, and patient safety while supporting our principals in navigating the dynamic healthcare landscape.

Position Summary

We are seeking a highly motivated and detail-oriented professional to support regulatory compliance and pharmacovigilance activities. This role is critical in ensuring adherence to all applicable regulations and guidelines set by Malaysian regulatory authorities for products imported and distributed by the Company.

The incumbent will also play a key role in SOP management, regulatory training, and supporting commercial teams in business development initiatives.

Key Responsibilities

Regulatory Affairs, Pharmacovigilance & Controlled Drug Management

• Manage pre-market and post-market regulatory activities, including product registration, licence renewals, import permits, special authorisations, product recalls, and lifecycle updates.
• Act as Deputy Pharmacovigilance (PV) Officer, overseeing PV-related functions such as regulatory reporting, audit participation, training, and closure of audit findings.
• Conduct local literature monitoring to support pharmacovigilance requirements.
• Oversee controlled drugs as Second Poison Licence Holder, ensuring full compliance with regulatory requirements.
• Review and approve marketing and promotional materials in accordance with regulatory guidelines.
• Manage registration and maintenance of sales and advertisement permits, including regulatory documentation and database tracking.
• Participate in meetings with principals and stakeholders to provide regulatory input and updates.

Regulatory Support & Compliance Advisory

• Prepare and review principal agreements related to regulatory and pharmacovigilance matters.
• Monitor regulatory updates and provide timely compliance advisory to management and internal stakeholders.
• Manage medical and product-related enquiries.
• Ensure accurate and timely billing for regulatory services.

Requirements

• Bachelor’s Degree in Pharmacy, Life Sciences, or related discipline
• Relevant experience in Regulatory Affairs and/or Pharmacovigilance within the pharmaceutical or healthcare industry
• Strong knowledge of Malaysian regulatory requirements (e.g. NPRA, poison licence, PV reporting)
• Detail-oriented with strong analytical and communication skills
• Ability to work independently and collaborate with cross-functional teams

Why Join Us

• Regional exposure with global pharmaceutical principals
• Opportunity to play a critical compliance and governance role
• Collaborative and professional working environment
• Career development within a growing healthcare organization

How to Apply

Apply via LinkedIn