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 / Asst. Manager - Regulatory Affairs (API)
Job Description:
- Preparation and submission of dossier as per CTD format.
- Coordination with R&D, QA, QC & production for regulatory requirements for dossier submission and approval.
- Liaison with clients / local licensees, regulatory authorities.
- Responsible for preparation of variation and renewal documents.
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
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Apply/Send resume at, ra@alembic.co.in
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