Product assessment, regulatory approval and product registration, variations to existing products and renewals, product license renewal and maintenance
Liaise with local regulatory authority including HSA and other authorities pertaining to regulatory affairs and license for business operation
Provides regulatory advises (Regulatory strategies and guideline requirements) to internal and external stakeholders.
Monitor and track the progress of regulatory activities and provide license renewal progress updates on regular basis
Follow up with authorities and counterparts on pharmacovigilance activities (e.g. Product recall handling, Field Safety Corrective Action, Adverse event reporting etc.).
License holder for controlled drugs
At least a Bachelor's Degree in Pharmacy/Pharmacology or equivalent.
A minimum 2 years of regulatory experience for pharmaceuticals
Interested applicants please send your resume to email@example.com
Bo Zhuang Mian
Manpower Staffing Services (S) Pte Ltd
Alexis, Zhuang Mian Bo EA License No.: 02C3423 Personnel Registration No.: R1872731