Regulatory Affairs
Experience : 2 to 8 Years
Markets : ROW, EU, US
Qualification : B.Pharma / M.Pharm
Job Description
• Keen Knowledge on Regulatory guidelines for finished product registration. Compilation and review the product dossiers for submission in CTD, ACTD.
• Gap analysis of the dossier and addressing the gaps before submission to MOH
• Handling the customer and MOH queries.
• Life cycle management of the product.
• Compilation and Submission of ANDA’s & EU dossiers.
• Post & Pre approval experience to file the applicable variations timely.
• Knowledge on EU, ICH and EMEA guidelines.
Work Location : Jeedimetla Unit VII
What to bring to the interview :
Academic documents, pay slips, appointment letters.
CTC particulars and ID proof.
Date : 26th May 2023 (Friday) & 3rd June 2023 (Saturday)
Time : 9.00 a.m. to 3.00 p.m.
Venue : Hetero Labs Limited, Unit VII
Plot No : 14,Jeedimetla,Qutubullapur(M), Medchal Dist., Hyderabad. T.S