Greetings from Glochem Industries Private Limited…!!!

We are looking for an Executive – Regulatory Affairs with 3 to 5 years of expertise in pharma manufacturing of APIs.

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Roles & Responsibilities:
> Experience in compilation and submission of different kind of amendments (Scaleup, SM vendor change, process changes) and annual updates
> Experience in issuing LOA’s to customer referring to DMFs
> Experience in addressing the response to deficiencies received from various regulatory authorities
> Experience in addressing the responses to queries received from various customers on applicant part of the DMF
> Good experience in analyzing the data that is received from plant QA and R&D and correlate with the submitted information compile the DMF/response to the deficiencies in accordance with the registration.
> Participating in discussion with R&D, QA and QC teams for new projects
> Co-ordination with respective departments to collect the documents for filings
> Compilation of DMFs under GDUFA checklist

Work location – Head Office ,Sanathnagar, Hyderabad.

Suitable applicants can reach me at [email protected]

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About Us:

Glochem Industries Private Limited. is a fast-growing Private Limited Pharmaceutical company that is lead by a professional and technically oriented team. The company’s strategy has always been to focus on a selected group of products and aim for a global leadership position in that API and has been successful in this. The company today is at a size of about 165 employees with annual sales revenue of about $15 million USD.