Walk-In Interview Hiring for Eugia Pharma Specialties Ltd
Department : Regulatory Affairs - CMC & Labeling (US Markets)
Experience : 03 to 08 Years
Specifications : M. Pharm
Job Description :
• Planning, reviewing and submission for assigned ANDA and NDA projects.
• Excellent drafting skills for FDA Deficiencies with high quality and regulatory standards in response.
• Evaluation and good interpretation of post approval changes.
• Submission of Supplements like CBE, CBE-30 and Prior Approval Supplement (PAS), Annual Reports.
• Review and authorizing regulatory change controls.
• Knowledge of eCTD, Module 2and 3.
• Formulate US Regulatory filing strategy for new projects.
Work Location : APL Research Center I
Sy.No.313&314, Bachupally
Medchal- Malkajgiri dist.
Hyderabad, Telangana-500090
Interested candidates can send their profiles to Umasri.Pinnamaneni@eugiapharma.com
Last Date : 25th December, 2023
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