Website Shilpa Biologicals Pvt Ltd

Shilpa Biologicals
Looking for Regulatory Team
JD of Sr. Executive- Regulatory Affairs
Qualification: Postgraduate in Life science (MSc Biotech/BTech biotech)
Experience: 4 to 6 years
Preparation and submission of Biologicals regulatory applications (NOC application, Import application, Clinical trial applications, marketing Authorization Applications, etc.) to Indian agency Preparation and submission of CTD/country specific dossiers (CMC, clinical and non-clinical sections) for emerging markets Having knowledge/exposure for regulated markets (USA and Europe) submissions. Must have good experience in reviewing the R&D, QA, QC data required for dossier compilation Should have experience in proofread (labelling) of  regulatory documentation. Provide RA support to CFT for audits Having well hand working experience dealing with
CDSCO offices and well versed with online portal like SUGAM. Managing electronic regulatory media and preparing
electronic submissions. Ideal candidate should have good exposure dealing with eCTD software Assist in getting notarized/legalized documents from commerce chamber and embassy and regulatory samples handling Passionate to take new challenges

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