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Regulatory Executive Singapore

PHARM-D SINGAPORE PRIVATE LIMITED

PHARM-D SINGAPORE PRIVATE LIMITED Singapore Singapore

2 months ago

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

- Monitor product registration status; product renewal, license application and renewal, variation submission

- 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
Singapore

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