Regulatory Submissions & Lifecycle Specialist – Malaysia

Organon; Kampung Malaysia Tambahan; Hybrid; MYR 120,000 - 240,000; Full time

Job summary

Organon in Malaysia seeks a Regulatory Specialist to manage all aspects of regulatory submissions and lifecycle activities for local products. The role emphasizes integrating scientific and regulatory knowledge to meet local laws and company procedures, while coordinating with cross-functional teams to enhance regulatory initiatives and supply continuity.

The incumbent will support post-marketing activities such as variations, renewals, and labeling, and may act as the regulatory license holder.

Qualifications

• Minimum of 2 to 5 years of industry experience in regulatory affairs in Local or MNC pharmaceutical company.
• University Degree, B.Sc. or higher in Health Sciences or equivalent.
• Local registered pharmacist is required.
• Sound knowledge of regulations within the assigned markets and expert in local regulatory processes and activities.

Responsibilities

• Develops product registration plans and strategies and communicates the strategy cross-functionally with minimal oversight.
• Timely preparation and submission of new Marketing Authorization Applications to local Health Authorities; maintain products through post-market regulatory dossiers.
• Archive and maintain regulatory data and documentation per policies and local requirements.
• Ensure compliance with global and local SOPs; report deviations and assist in CAPAs locally.
• Support local audits, inspections and readiness activities; respond to findings/observations.
• Assist in developing local procedures for the department and evaluate processes for improvements.
• Identify procedural gaps and implement solutions with stakeholders.
• Assist in drug shortage management and regulatory reporting in collaboration with Quality and Supply Chain.

Skills

Regulatory affairs

Pharmaceutical compliance

Education

Bachelor in Health Sciences (B.Sc.)

Job description

Organon in Malaysia seeks a Regulatory Specialist to manage all aspects of regulatory submissions and lifecycle activities for local products. The role emphasizes integrating scientific and regulatory knowledge to meet local laws and company procedures, while coordinating with cross-functional teams to enhance regulatory initiatives and supply continuity.

The incumbent will support post-marketing activities such as variations, renewals, and labeling, and may act as the regulatory license holder.