Regulatory Executive

3 days ago

Singapore PHARM-D SINGAPORE PRIVATE LIMITED Full time

**Job Description**:

- Technical enquiry support for unregistered products evaluation.
- Pharmacovigilance responsible person-PBRER, RM, recall
- 2nd Checker on hospital evaluation/cold chain mapping
- 2nd checker for Package inserts translation (Japan/Korea language)
- Review of Controlled Drug recording/annual report submission
- Prepare, review, and submit dossiers to regulatory authorities for registration of therapeutic products/medical devices
- Attend to queries posted by regulatory authorities in a timely manner
- Ensure company’s product comply with regulatory requirements
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
- Attend to Post-Market Surveillance Activities/Request from regulatory authorities especially for pharma
- Perform GDP, GDPMD, and GVP internal/external audits
- Liaison with HAS for pharmacovigilance/audit.
- QA release to ensure compliance of product labels and COA by performing checking prior to release in the market
- Dear Healthcare, Professional letter for RMP/Product launch/Product recall
- Approval on labelling amendments
- Review labeling and marketing materials to ensure compliance with the relevant regulatory requirements
- Review of marketing campaign and material to ensure compliance to Advertisement Act.
- Review of agency technical agreement involving regulatory affair.

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