About Company:
Established in 1907, Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates. Alembic is the market leader in the Macrolides segment of anti-infective drugs in India. Alembic’s manufacturing facilities are located in Vadodara and Baddi in Himachal Pradesh. The plant at Vadodara has the largest fermentation capacity in India. The Panelav facility houses the API and formulation manufacturing (both US FDA approved) plants. The plant at Baddi, Himachal Pradesh manufactures formulations for the domestic and non-regulated export market. The company has a state of the art Research Centre at Vadodara.
Website
http://www.alembic-india.com
Vacancy Details:
Job Description:
Alembic Pharmaceutical Ltd. is looking competent professional at Sr. Executive/ Asst. Mgr/ Dy. Mgr for Regulatory Affairs department based at Corporate Office, Vadodara Gujarat.
Interested candidates with suitable experience may share their resume to hrd@alembic.co.in.
Please share this position with your friends/ colleagues whom you think is the right fit for this role.
DEPARTMENT: REGULATORY AFFAIRS
Position: Sr. Executive / Asst. Mgr./ Dy. Mgr
based at Corporate Office-Vadodara
Job Criteria:
1. B. Pharm or M. Pharm qualification having experience between 7-15 yrs. with dossier filling experience in MEXICO or ASEAN Country.
2.Knowledge for review of quality documents like executed batch documents, method validation, change
3.Good communication skill
Job Responsibility:
1.Compilation and review of product license applications, variations, and renewals for Mexico or ASEAN countries as per regulatory requirements respectively with minimal supervision
2.Manages electronic documents and creates electronic submissions in CTD format.
3.Preparation and review of responses to authority questions during registration and product lifecycle.
4.Keep track of assigned projects and follow-ups to ensure the Dossier is delivered as per set timeline/commitments.
5.Designing, Reviewing & Approval of Artwork required for registration purposes.
6.Dossier due diligence for products being in-licensed from other company
7.Support in preparing the meeting materials as needed, eg, regulatory project status/submission/ approval information monthly, quarterly or yearly.
Interested professionals may share their CVs to hrd@alembic.co.in stating position code “RA-2025” in subject line
www.alembicpharmaceuticals.com
