Alembic Limited is a leading Pharmaceutical company having a strong domestic and international presence in Formulation, Bulk Drugs and Drug Intermediates, with turnover above Rs. 700 crore. Our unwavering focus on innovation, self- reliance and indigenous technology and import substitution is the secret of our nine decades of enviable market presence. Equipped with our portfolio of world class healthcare products, today we are making a difference in people’s life in over 65 countries worldwide. At Alembic, we recognize that Research and Development is vital for our survival and growth as leading pharmaceutical firm in India. Research and Development at alembic is focused on fermentation technology, strain improvement, industrial enzymes, non- infringing process developments for API & intermediates, development of innovative formulations, NDDS. The Department of Scientific and Industrial Research (DSIR) of the Government of India recognize Alembic’s Research and Development unit since 1975. Research and Development efforts at Alembic are focused on 3 broad categories
- Chemistry & Synthesis
- Formulations Development
- Contract/Collaborated Research.
Alembic Research Centre, a division of Alembic Ltd. is based at Vadodara, India and offers state-of-art research infrastructure spread over an area of 120000 sq.ft. The facilities have been designed according to cGMP/ cGLP standards and currently have scientists on a multi- year agreement.
Designation: Manager / Asst. Manager / Sr. Executive – Regulatory Affairs
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.
Desired Profile: Candidate should be M.Sc / B.Pharm with experience of CTD, EU applications and ANDA applications will be an advantage.
Experience : 5 – 10 Years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area : Healthcare, Medical, R&D
Education: UG – B.Pharma – Pharmacy;B.Sc – Any Specialization;PG – M.Pharma – Pharmacy;M.Sc – Any Specialization
Location : Vadodara/Baroda
Contact
Mr. Himanshu Jani.
Alembic Ltd.
3rd Floor, HRM Division, Corporate Building,
Alembic Road
Baroda – Gujarat ,INDIA 390003
Telephone : 91-265-3007702,3007743
Website :http://www.alembic-india.com
Reference :AV – RA
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