Regulatory Submissions Specialist (Malaysia)

Organon; Kuala Lumpur; Hybrid; MYR 60,000 - 90,000; Full time

Job summary

Organon Malaysia seeks a Regulatory Affairs Specialist to manage regulatory submissions for local products, ensure lifecycle management, and collaborate with cross-functional teams to meet local regulatory requirements.

You will prepare MAAs, variations, renewals, and post-market dossiers, while maintaining regulatory data and supporting audits and readiness activities. A local pharmacist with a health-sciences degree is required.

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 (including chemistry, biochemistry, physiology) or equivalent.
• Local registered pharmacist is required.

Responsibilities

• Develops product registration plans and strategies and working cross-functionally to review and communicate the registration strategy with minimal oversight.
• Timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers including variations, renewal applications and supplemental marketing authorization in accordance with local regulations and global standards.
• Archiving and maintenance of regulatory data and documentation in accordance with department and company policies and local requirements including licenses, import and distribution of pharmaceuticals and medical devices.
• Ensure compliance with global and local SOPs and report deviations or compliance concerns; assist in corrective actions locally.
• Support local audits, inspections and readiness activities including audits of contractual partners/vendors and response to findings/observations.
• Proactively identifies procedural gaps and challenges and implements solutions in collaboration with stakeholders.

Skills

Regulatory affairs

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in Health Sciences or equivalent

Local registered pharmacist

Job description

Organon Malaysia seeks a Regulatory Affairs Specialist to manage regulatory submissions for local products, ensure lifecycle management, and collaborate with cross-functional teams to meet local regulatory requirements.

You will prepare MAAs, variations, renewals, and post-market dossiers, while maintaining regulatory data and supporting audits and readiness activities. A local pharmacist with a health-sciences degree is required.