Opening for Sr. Executive / Executive in Regulatory Affairs at Alembic Pharma
Alembic Limited, with an established presence in the Indian pharma industry has a proud, historical track record going back one hundred years. With a turnover in excess of Rs1000 crores today, Alembic Limited is one of India’s leading integrated pharmaceutical companies. We continue to enjoy leadership positions in antibiotics, anti-infective, anti-cough and also have significant worldwide presence in specialty therapeutic areas such as cardiology, neurology, diabetology, etc. We have also plans for expansion in Ophthalmic etc.
Post: Sr. Executive / Executive – Regulatory Affairs
• Guidance to R&D, ADL, Manufacturing, Quality for different regulatory requirements, Compilation of DMFs for US, Europe and other Regulatory agencies.
• Review of all technical documents required for the submission of DMFs and ANDAs.
• Preparation and submission of DMFs and ANDAs to regulatory authorities with the time frame.
Candidate should be M.Sc with experience of CTD, EU applications and ANDA applications will be an advantage.
Experience: 2-5 years
Education: B.Pharma,B.Sc, M.Sc, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
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