18 August, 2022
Rusan Pharma is Hiring Sr. Manager / Assistant General Manager – Regulatory Affairs
Ideal candidate must have sound exposure (minimum 10 years) and knowledge of Regulatory Affairs for US and Europe Market as well as ROW Market, with a reputed pharma Organization.
• 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 response like Chemistry, Microbiology, GDUFA & Telephonic etc.
• Submission of Regulatory reports like Amendments, annual updates.
• Excellent Team handling skills with an ability to manage a team size of more than 10 employees.