About Indoco Remedies:
Indoco Remedies Ltd is a fully integrated, research-oriented pharma company engaged in the manufacturing and marketing of Formulations (Finished Dosage Forms) and Active Pharmaceutical Ingredients (APIs). We have seven decades of presence in the Indian Pharma market and a strong foothold in the international market across 55 countries. Indoco, a USD 166 million company, employs around 6000 personnel, including over 300 skilled scientists.
We have 9 manufacturing facilities, out of which, 6 are for finished dosages and 3 for APIs, supported by a state-of-the-art R&D centre at Rabale, Navi Mumbai and a Clinical Research Organization at Hyderabad. Our manufacturing facilities are of the highest regulatory standards, complying with WHO-cGMP guidelines and have been approved by various regulatory authorities such as USFDA, UK-MHRA, TGA-Australia, SAHPRA-South Africa, NDA-Uganda, TFDA-Tanzania, MOH-Ukraine, PPB-Kenya, DPML-Ivory Coast, etc.
Indoco has strengthened its wings in the international markets and offers complete solutions, including product development, manufacture and supply of Finished Dosages, APIs and Intermediates to generic companies worldwide. We have a large basket of products backed by ANDAs / eCTD Dossiers and Drug Master Files (DMFs).
Expertise in Research & Development, backward integration in API in select products, own CRO set-up, excellence in Finished Dosages manufacturing and a strong customer base will ensure consistent growth in the Company’s Domestic, as well as International business.
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About Indoco Remedies vacancy:
We are hiring
Position : Senior Executive/Asst. Manager – Regulatory Affairs
Qualification : B.Pharm./M.Pharm.
Market : Europe
Experience : 6 to 10 years of Europe Market Experience. Europe Experience should be recent and is a must.
Job Description :
i. Preparation and compilation, review, and submission of new product registrations, repeat use MRP applications and duplicate marketing authorizations.
ii. Evaluation and submission of post approval changes and coordination for product life cycle management.
iii. Compilation of responses for deficiency received from agency.
iv. Coordination and follow up with supporting teams (R& D/ADL/Plant/BD/Legal).
v. Evaluation for Change controls. And providing information to manufacturing location/business customer/supply chain about regulatory submission and approvals.
vi. Review of technical documents like MFC/MPC, BMR, BPR stability protocol, specification etc.
vii. Liaising with Customers for different documents, variation, and new product registration.
viii. Due diligence for product registration documents and compilation of requirement matrix.
Please share your resume or refer suitable candidates on : rajiv.farkade@indoco.com
More Jobs Info:
FAQ Related To Indoco Remedies:
Q. Who is the owner of Indoco Remedies?
Ans: Mr Suresh G. Kare, Chairman & Managing Director, Indoco Remedies.
Q. When were indoco remedies was established?
Ans: 1945.
Q. Who is the founder of Indoco Remedies?
Ans: Mr. Govind Ramnath Kare
