Job Responsibilities

• Manage the regulatory submission process by ensuring timely supply of supporting information and regulatory dossier review to achieve timely approval from regulatory authorities. 
• Manage questions from regulatory authorities concerning a regulatory submission by ensuring timely supply of response and supporting information to achieve timely approval from authorities. 
• Manage the implementation of registered commitments to ensure continuous compliance with inspection requirements. 
• Support site change control, investigations and batch release, improvement initiatives through the provision of regulatory advice and act as an initiator or enabler for change implementation. 
• Support external and internal audits. 
• Act as the QA for the review and subsequent implementation actions for changes to pharmacopoeia requirements. 
• Conduct expert reviews of information, facilities and practices used by the business and external parties to ensure implementation of required regulatory strategies and compliance with standards. 

Job Requirements

• Degree graduate in Pharmaceutical, Medical or equivalent
• Knowledge in regulatory dossier review

Only shortlisted candidate will be notified.

To apply, please visit to www.gmprecruit.com and search for Job Reference: 22012

GMP Recruitment Services (S) Pte Ltd | EA Licence: 09C3051 | EA Personnel: Jaremy Ong | Registration No: R1876766