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Opening for Sr. Executive / Executive in Regulatory Affairs at Alembic Pharma


Clinical courses


Clinical research courses

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

Job Description:
• 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 Profile:
Candidate should be M.Sc with experience of CTD, EU applications and ANDA applications will be an advantage.

Additional Information:
Experience: 2-5 years
Location: Vadodara

Education: B.Pharma,B.Sc, M.Sc,  M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA

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