Specialist Regulatory Affairs

About the role

Organon is hiring a Specialist Regulatory Affairs for Singapore and Brunei. The specialist handles all aspects of regulatory submissions, combining scientific and regulatory knowledge so that new and established products meet local legislation and company procedures. The role covers post-marketing lifecycle management (change management, line extensions, re-registrations, claims, labeling support) and external regulatory surveillance, works closely with cross-functional teams and reports to the Country Regulatory Lead.

Key responsibilities

• Develop product registration plans and strategies, reviewing and communicating them with minimal oversight
• Prepare and submit new Marketing Authorization Applications to local Health Authorities, and maintain authorized products through post-market dossiers such as variations, renewals and supplemental marketing authorizations
• Maintain regulatory data and documentation (product licenses, import and distribution of pharmaceuticals and medical devices)
• Ensure compliance with global and local SOPs, report deviations and help prepare CAPAs
• Support local audits, inspections and vendor audits, and respond to findings
• Help develop local procedures and identify procedural gaps
• May support drug shortage management and regulatory reporting, working with local Quality and Supply Chain

Required profile

• Bachelor's degree or above in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry or a related scientific discipline
• Minimum 3-5 years of regulatory affairs experience in the pharmaceutical industry, including product registrations, post-approval submissions, lifecycle management, renewals, labeling updates and compliance
• Working knowledge of Singapore pharmaceutical regulations is preferred
• Strong project management, planning and organizational skills, and ability to work independently and in a multicultural environment

Required skills

• Excellent communication, influencing and stakeholder management skills
• Proficiency in Microsoft Office and regulatory information management systems is an advantage

What we offer

• 10% flexible work arrangements
• Hybrid work arrangement
• No relocation required; visa sponsorship not available