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Regulatory Executive - Singapore - PHARM-D SINGAPORE PRIVATE LIMITED

PHARM-D SINGAPORE PRIVATE LIMITED

Verified Company

Singapore

1 month ago

Posted by:

Wei Jie

beBee Recruiter

Job Description:

Technical enquiry support for unregistered products evaluation.
Pharmacovigilance responsible personPBRER, 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.

Assistant Sales Manager