Regulatory Affairs Executive - Pharmaceutical

Location Singapore, Singapore
Job reference Exp-HCLS_1558074762
Salary AWS
Consultant name Alexis Bo Zhuang Mian
Consultant email alexis.bo@experis.com.sg
Consultant contact no. 65515307
EA License No. 02C3423
Consultant Registration No. R1872731

Responsibilities:

  • 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


Requirements:

  • 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 alexis.bo@experis.com.sg

Bo Zhuang Mian

R1872731

Manpower Staffing Services (S) Pte Ltd

02C3423

Alexis, Zhuang Mian Bo EA License No.: 02C3423 Personnel Registration No.: R1872731