Regulatory Affairs Specialist — Hybrid, Flexible Work

Organon LLC; Singapore; Sur place; SGD 70 000 - 110 000; Plein temps

Avantages offerts par ce poste

Hybrid work arrangement

Flexible work arrangements

No relocation required

Résumé du poste

Organon LLC in Singapore seeks a Regulatory Specialist to manage local regulatory submissions and lifecycle activities. You will collaborate with cross-functional teams to ensure compliance with local authorities and global standards, enabling timely registrations and renewals.

The role requires 3–5 years in regulatory affairs, strong project management, and knowledge of Singapore regulations. Hybrid work arrangements are supported, with a focus on ensuring supply continuity and regulatory

Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences or related field.
• 3–5 years in regulatory affairs in pharma, with lifecycle management.
• Knowledge of Singapore regulations and submission requirements.
• Strong project management and stakeholder skills.

Responsabilités

• Develops product registration plans and strategies.
• Prepare and submit marketing authorization applications to local authorities.
• Maintain regulatory data and documentation per policies.
• Ensure SOP compliance and implement CAPAs locally.
• Support audits, inspections, and vendor responses.
• Identify process improvements with stakeholders.

Connaissances

Regulatory affairs

Project management

Communication

Cross-functional collaboration

Attention to detail

Formation

Bachelor's degree in Pharmacy or Life Sciences

Outils

Regulatory systems

Description du poste

Organon LLC in Singapore seeks a Regulatory Specialist to manage local regulatory submissions and lifecycle activities. You will collaborate with cross-functional teams to ensure compliance with local authorities and global standards, enabling timely registrations and renewals.

The role requires 3–5 years in regulatory affairs, strong project management, and knowledge of Singapore regulations. Hybrid work arrangements are supported, with a focus on ensuring supply continuity and regulatory