Our Company was incorporated as Emcure Pharmaceuticals Private Limited on April 16, 1981 as a private limited company under the Companies Act, 1956.
We are a fast growing Indian pharmaceutical company engaged in developing, manufacturing and marketing a broad range of pharmaceutical products globally. Our core strength lies in developing and manufacturing differentiated pharmaceutical products in-house, which we commercialize through our marketing infrastructure across geographies and relationships with multi-national pharmaceutical companies.
Job Title:Â Â Â Asst. Manager / Executive
No. of Posts:Â Â 3
Job Description:
Key Responsibilities:
USA Markets
# Handling of post approval submissions Annual Reports, CBE, CBE-30, & PAS supplements.
# Handling of PADERS
# Review of change controls, deviations, QMS and product related documents
Position : Asst. Manager / Executive
Key Responsibilities:
# Evaluation of the comments/deficiencies received from Agency and to identify the requirements of deficiency response of ASMF/DMF/CEP, Australia,NZ, and other markets.
# Evaluation of the comments/deficiencies received from Agency and to identify the requirements of deficiency response of Druh Product Applications for ROW/Emerging Markets (Asia, Africa, MENA,CIS and Latin America).
# co-ordinations with internal and external stakeholders (R&D, Plant QA/QC etc) review and collate the data/documents for preparation of deficiency responses.
# Responses
Position: Executive
# Review of deficiencies received from USFDA.
# Evaluating the activities required and coordinating with the stakeholders to complete the activities within the assigned agency target.
# Maintaining a status of the deficiencies from US, tracking and timely follow up.
Qualifications:Â
PG – MS/M.Sc(Science) – Chemistry, M.Pharma – Pharmacy
Doctorate – Doctorate Not Required
