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Regulatory Conformance Officer

3 weeks ago

Singapore GMP Group Full time

**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

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