Regulatory Affairs Coordinator (Healthcare | Pharma MNC)
Responsibilities
- Monitor emerging regulatory trends and ensure integration into company procedures.
- Support regulatory submissions, product registrations, renewals, and variations across domestic and regional markets.
- Assess product, manufacturing, labeling, and packaging changes for regulatory compliance.
- Provide input for product development, clinical studies (GCP), and manufacturing transfers.
- Liaise with HSA and global regulatory authorities; assist in negotiations and field actions.
- Act as an internal consultant on regulatory issues, including recalls, safety reporting, and promotional activities.
- Prepare reports, submissions, presentations, and maintain regulatory documentation.
Education and Experience
- Min Degree in any science related field
- Minimum 2 - 3 years of experience in either domestic and regional regulatory affairs would have an advantage
- Familiar with regulatory affairs such as NDA, variation and renewal of product registrations in Pharmaceutical industry (manufacturer or distributor) would be at an advantage
- Pharmacovigilance (or safety monitoring/reporting) experiences preferred but not mandatory
If you are interested in the position, do kindly drop your most updated resume to