Regulatory Manager (Healthcare Distribution)

DCH Auriga (Malaysia) Sdn Bhd; Shah Alam; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading Malaysian regulatory affairs company is seeking a Regulatory Manager to oversee compliance for imported and distributed products. Responsibilities include acting as the Company’s Poison License holder, reviewing promotional materials, and ensuring product registration and post-market compliance. The ideal candidate should have a Registered Pharmacist qualification and experience in regulatory activities and pharmacovigilance. This role offers strategic involvement in regulatory standards and collaborations with commercial teams.

Qualifications

• Experience in regulatory activities for imported and distributed products.
• Knowledge about Malaysian regulatory standards and compliance.
• Strong communication skills for industry engagements.

Responsibilities

• Oversee all regulatory activities for products.
• Act as the Company’s Poison License holder.
• Review and approve promotional materials.
• Ensure product registration and compliance.
• Serve as the primary contact for pharmacovigilance.
• Represent RA on the Leadership Team.
• Support audits and good distribution practices.
• Collaborate with commercial teams on new product launches.

Skills

Regulatory compliance

Pharmacovigilance

Product evaluation

Medical communications

Education

Registered Pharmacist qualification

Job description

Oversee all regulatory activities for imported and distributed products

Act as the Company’s Poison License holder

Review and approve promotional materials and manage advertisement permits

Ensure product registration, notification, and post-market compliance

Serve as the primary contact for pharmacovigilance and controlled drug handling

Represent RA on the Company’s Leadership Team

Ensure business operations meet Malaysian regulatory standards

Support audits, product sampling, and good distribution practices

Collaborate with commercial teams on product evaluation and launch planning

Provide regulatory guidance for marketing and sales initiatives

Deliver training on pharmacovigilance and regulatory topics to internal teams

Represent the Company in industry events and regulatory engagements (e.g., NPRA, MDA)

Lead medical communications and respond to product-related inquiries

Support clinical product training for sales teams and healthcare professionals

Unlock job insights

Your application will include the following questions:

• Which of the following types of qualifications do you have?
• Are you willing to undergo a pre-employment background check?
• Are you willing to undergo a pre-employment medical check?
• How many years' experience do you have as a Regulatory Manager?
• How many years' experience do you have as a Registered Pharmacist?
• How many years' experience do you have as a Pharmacovigilance Specialist?