REGULATORY AFFAIRS PHARMACIST

VIPRECISION SDN BHD; Subang Jaya; On-site; MYR 45,000 - 78,000; Full time

Job summary

VIPPRECISION SDN BHD invites a regulatory affairs professional to support submissions for healthcare and diagnostic products in Malaysia. You will coordinate dossiers, liaise with authorities such as Medical Device Authority and National Pharmaceutical Regulatory Agency, and ensure timely regulatory maintenance.

Responsibilities include maintaining regulatory records, preparing SOPs, and collaborating with internal teams and external consultants to ensure compliant market access.

Qualifications

• Bachelor’s degree in Pharmacy or equivalent recognized in Malaysia.
• Registered pharmacist with valid APC preferred.
• 1–3 years working experience preferred; fresh candidates with strong interest in regulatory affairs encouraged to apply.

Responsibilities

• Support preparation and coordination of regulatory submissions for healthcare and diagnostic products.
• Assist in compiling and reviewing product registration dossiers and supporting documentation.
• Liaise with authorities including Medical Device Authority and National Pharmaceutical Regulatory Agency on regulatory matters.
• Monitor regulatory requirements, updates, and submission timelines.
• Coordinate documentation for product registrations, renewals, variation submissions, and regulatory maintenance activities.
• Support establishment license, regulated import, and related compliance activities.
• Maintain regulatory records, licenses, permits, and documentation.
• Coordinate with internal teams, principals, suppliers, and external consultants on regulatory matters.

Skills

Documentation

Coordination

Communication

English proficiency

Regulatory awareness

Education

Bachelor’s Degree in Pharmacy

Tools

MS Office

Job description

Regulatory Affairs & Product Registration

Support preparation and coordination of regulatory submissions for healthcare and diagnostic products.

Assist in compiling and reviewing product registration dossiers and supporting documentation.

Liaise with relevant authorities including Medical Device Authority and National Pharmaceutical Regulatory Agency on regulatory matters.

Monitor regulatory requirements, updates, and submission timelines.

Coordinate documentation and information required for product registrations, renewals, variation submissions, and regulatory maintenance activities.

Support establishment license, regulated import, and related compliance activities.

Regulatory Compliance & Coordination

Support regulatory compliance activities for regulated healthcare products and imports.

Assist in maintaining regulatory records, licenses, permits, and documentation.

Coordinate with internal teams, principals, suppliers, and external consultants on regulatory-related matters.

Participate in internal compliance preparation and documentation activities.

Support implementation and maintenance of SOPs and regulatory documentation processes.

Authority & External Liaison

Act as liaison with government authorities and external stakeholders for regulatory and compliance-related matters.

Coordinate with logistics agents, customs brokers, and suppliers regarding regulatory documentation and import requirements.

Attend occasional meetings with authorities, principals, or external partners when required.

Cross-Functional Support

Work closely with management on regulatory planning and market access activities.

Provide internal regulatory guidance and support to commercial and operational teams.

Support continuous improvement initiatives related to regulatory operations and documentation workflows.

Requirements

Bachelor’s Degree in Pharmacy or equivalent qualification recognized in Malaysia.

Registered pharmacist with valid APC preferred.

1–3 years working experience preferred; fresh candidates with strong interest in regulatory affairs are encouraged to apply.

Experience in community pharmacy, hospital pharmacy, regulatory affairs, healthcare, diagnostics, or biotechnology industry will be an added advantage.

Good understanding or interest in healthcare regulatory environment in Malaysia.

Strong documentation, coordination, and communication skills.

Detail-oriented, organized, and willing to learn.

Able to work independently while collaborating with cross-functional teams.

Proficient in English, both written and spoken.