Established during the Swadeshi Movement of India, Biological E. Limited (BE) started during a time when the nation sought access to critical healthcare products. Founded and led by Dr. DVK Raju, Biological E. Limited commenced its operations in 1953 as a biological products company manufacturing liver extracts and anti-coagulants. With an objective of transitioning from treating diseases to preventing them, Biological E. Limited launched its Biotechnology Division (now Vaccines and Biologics Division) and commenced large-scale production of DPT vaccines as early as 1962.
Assistant Manager / Deputy Manager
Department : Regulatory Affairs (Injectable Formulations) USA / EU / Canada markets
Qualification : M.Pharmacy / B.Pharmacy,
Experience : 1 - 10 years of experience
Work Location : Shameerpet - Hyderabad
Job Skills :
• Good regulatory work experience in sterile injectable formulations (In regulated markets like USA/EU/Canada)
• Combined work experience in regulated and emerging markets is more desirable
• Knowledge on drug-device combination products/complex products
• Knowledge on eCTD tools, Labeling/ SPL preparation
• Good communication and drafting skills
• Ability to work with minimum guidance
Job description :
• Dossier review & compilation for global markets
• Post approval Life cycle management
• Dossier publishing using eCTD tools
• Product development support like CC, meeting package, strategy preparation
• Review of master documents for submission
• Coordination with CFT for regulatory requirements
Assistant Manager / Deputy Manager
Department : Regulatory Affairs (Injectable Formulations) - Emerging markets
Qualification : M.Pharmacy / B.Pharmacy
Experience : 10 -12 years of experience
Work Location : Shameerpet - Hyderabad
Job Skills :
• Good regulatory work experience in sterile injectable formulations in global markets
• Combined work experience in regulated and emerging markets is more desirable
• Knowledge on Labeling preparation
• Good communication and drafting skills
• Ability to work with minimum guidance Job description:
• Dossier review & compilation for global markets
• Post approval Life cycle management
• Review of master documents for submission
• Coordination with CFT for regulatory requirements
Interested candidates please share your Profile on or before 7th April 23 to kishore.dodda@biologicale.com please mention mail subject as "RA -712"
Last Date : 7th April, 2023
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