Alembic Pharmaceuticals 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 Rs. 1200 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
Alembic Pharmaceuticals 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 Rs. 1200 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. Alembic"s manufacturing facilities are at Vadodara, Panelav in Gujarat, and Baddi in Himachal Pradesh. The facilities are approved by the US FDA, EDQM, TGA, MHRA, and MCC. Alembic Research Center (ARC) a world-class research organization provides a comprehensive range of services in the areas of synthetic chemistry, formulations, NDDS, as also preclinical pharmacology, bioequivalence / bioanalytical studies, etc. ARC, designed to state-of-the-art GLP standards, is spread over an area of 120,000 sq ft, manned by over 300 scientists working on latest technology and systems. Our current employee strength is in excess of 4500 across the country. A continuously expanding organization, we invite dynamic, result-oriented professionals to join us across various functions.
Our group company viz. Alchemy is the brainchild of the 103-year-old Alembic group of companies which has a diversified portfolio of businesses including pharmaceuticals, healthcare, glassware, engineering and chemicals. Our leadership team possesses an experience of developing over 10 million sq. ft. of land and more than 2 million sq. ft. of built-up space which include integrated residential townships, schools, industrial plants, commercial offices, and hospitals. We are integrating this legacy of uncompromising build quality, intelligent design and construction methodology into all our projects. Our vision is to create value for all stakeholders and to turn any project into a successful and inspiring place to work, live and explore.
Regulatory Affairs Jobs Opening in Alembic | Designation | Opening IN Regulatory Affairs. |
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| Job Description | - Compilation/preparation of registration dossier for ROW countries.
- Should be able to prepare dossier as per eCTD/ACTD format.
- Should be aware about regulatory requirements (e.g. ICH guidelines, WHO GMP requirements, Stability studies, BE studies, COPP) for ROW countries.
- Should be able to review technical documnts received from R&D/ADL etc."
- Preparation of dossiers for Tenders for ROW countries
- Maintenance of documentation
- Keeping database updated Database of various technical, legal and clinical documents required for a registration dossier.
- Maintenance of sample, example - Finished products, Raw materials, WRS, Packaging materials etc.
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| Desired Profile | Please refer to the Job description above |
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| Experience | 4 - 9 Years |
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| Industry Type | Pharma / Biotech / Clinical Research |
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| Role | Regulatory Affairs Manager |
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| Functional Area | Legal, Regulatory, Intellectual Property |
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| Education | UG - B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy
DOCTORATE - Doctorate Not Required |
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| Location | Vadodara/Baroda |
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| Keywords | Regulatory affairs, RA, ROW, dossiers, formulations |
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| Contact | Mr Himanshu Jani
Alembic Pharmaceuticals Limited
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| Website | http://www.alembic-india.com |
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| Job Posted | 02 Jan |
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