Hybrid Regulatory Submissions Specialist, Malaysia

Biopharma Careers; Malaysia; Hybrid; MYR 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Organon Malaysia Sdn Bhd is seeking a Regulatory Affairs Specialist to manage regulatory submissions for Malaysia. You will coordinate cross-functionally, prepare MA applications, and maintain post-market registrations with timely variations and renewals under local regulations and global standards.

The role requires 2–5 years in regulatory affairs and a degree in Health Sciences or equivalent, with local pharmacist registration.

Qualifications

• University degree in Health Sciences or equivalent (chemistry/biochemistry/physiology).
• Local registered pharmacist is required.
• 2–5 years of regulatory affairs experience in pharma.

Responsibilities

• Develops product registration plans and strategies with cross-functional teams.
• Prepares and submits new Marketing Authorization Applications to local Health Authorities.
• Maintains authorized products via variations, renewals and supplements per local/global standards.
• Archives and maintains regulatory data/docs per policies and local requirements.
• Ensures compliance with SOPs and tracks CAPAs for non-compliance issues.
• Assists in local audits/inspections and vendor/partner responses.
• Develops local procedures aligning with regional/global standards.
• Supports drug shortage management and regulatory reporting as needed.

Skills

Regulatory affairs

Compliance knowledge

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in Health Sciences

Licensed pharmacist

Job description

Organon Malaysia Sdn Bhd is seeking a Regulatory Affairs Specialist to manage regulatory submissions for Malaysia. You will coordinate cross-functionally, prepare MA applications, and maintain post-market registrations with timely variations and renewals under local regulations and global standards.

The role requires 2–5 years in regulatory affairs and a degree in Health Sciences or equivalent, with local pharmacist registration.