Regulatory Submissions Specialist – Singapore & Brunei

Organon Comercializadora S de RL de C.V; Singapore; Sur place; SGD 80 000 - 110 000; Plein temps

Résumé du poste

Organon Comercializadora S de RL de C.V. seeks a Regulatory Specialist to manage all regulatory submissions in Singapore and Brunei.

The role combines science with regulatory know-how to ensure products meet local laws and company standards, while overseeing post‑marketing lifecycle activities and surveillance. You will collaborate with cross-functional teams to drive regulatory initiatives, maintain compliance, and support supply continuity.

Qualifications

• Bachelor's degree or above in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry, or a related scientific discipline.

Responsabilités

• Develops regulatory submission plans and strategies and works cross-functionally to review and communicate the registration strategy.
• Timely preparation and submission of new Marketing Authorization Applications to local Health Authorities, with maintenance of authorized products through variations, renewals, and post-market dossiers.
• Archiving and maintenance of regulatory data and documentation in accordance with policies and local requirements, including licenses and import/distribution records.
• Ensure compliance with global and local SOPs and contribute to CAPA development and implementation.
• Support local audits, inspections, and readiness activities including vendor audits and responses to findings.
• Assist in developing local procedures for the department and evaluate processes for efficiency improvements.
• Identify procedural gaps and implement collaborative solutions with stakeholders across functions.
• May assist in drug shortage management and regulatory reporting in collaboration with Quality and Supply Chain.

Connaissances

Regulatory affairs experience

Pharma industry knowledge

Regulatory submissions

Singapore regulatory knowledge

Regulatory interpretation

Project management

Stakeholder management

Cross-functional teamwork

MS Office

Formation

Bachelor's degree or above in Pharmacy or related scientific discipline

Outils

MS Office

Description du poste

Organon Comercializadora S de RL de C.V. seeks a Regulatory Specialist to manage all regulatory submissions in Singapore and Brunei.

The role combines science with regulatory know-how to ensure products meet local laws and company standards, while overseeing post‑marketing lifecycle activities and surveillance. You will collaborate with cross-functional teams to drive regulatory initiatives, maintain compliance, and support supply continuity.