RUSAN PHARMA LTD !!!
We are looking for "Sr. Manager" / "Assistant General Manager" - Regulatory Affairs, to be based at our Corporate Office at Charkop, Kandivli (West).
The ideal candidate must have sound exposure (minimum 10 years) and knowledge of Regulatory Affairs for the US and Europe Market as well as ROW Market, with a reputed pharma Organization.
Job Role:
• Candidate should have experience of Regulatory filings into regulated markets (US/EU) as well as emerging markets.
• Review of in-house Dossiers as per Good Regulatory Practices for its adequacy and accuracy.
• Compilation of Regulatory and Non-Regulatory documents / Dossiers in Regulatory Affairs.
• Compilation of Regulatory Documents in CTD & eCTD format
• Compilation of Annual reports, Amendments,
• Handle Query responses like Chemistry, Microbiology, GDUFA & Telephonic, etc.
• Submission of Regulatory reports like Amendments, and annual updates.
• Excellent Team handling skills with an ability to manage a team size of more than 10 employees.
Interested candidate can share their resume through e-mail at corporatehr@rusanpharma.com / niileshvthakkar@rusanpharma.com or through WhatsApp at +91 - 9029444419.
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