Regulatory Affairs

Acme Services

Mumbai

4-8 Years

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Posted a month ago
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Job Description

preparation and submission of registration dossier, renewal application and variation application for ANDA / ROW submission
Preparation of respective CTD sections and submission of final query response to agency
Preparation and submission of documents for national phase to respective European regulatory agency to receive national approval
To upload documents in national portal for respective European regulatory agency
Co-ordination with different department for getting required data for compilation of registration dossier, renewal application and variation
Review of the mockups for all regulatory submissions and commercial supplies
Maintenance of internal database
Co-ordination with consultant for national submissions, product information translation, readability testing etc
Review and approval of change control and deviations
Coordination with customer and consultant in order to timely submissions of new applications, query responses, variations and renewals
Review of variation packages

More Info

Job Type:

Permanent Job

Industry:

Human Resources

Role:

Regulatory Affairs Executive

Function:

Pharmaceutical/Biotechnology

Employment Type:

Full time

Open to candidates from:

Indian

About Company

Acme Services

We have a huge experience in recruitment for almost every industry from accounting to automobiles and from manufacturing to healthcare and IT. We strive to deliver excellence by understanding the necessity of our client and discovering true talent for them. "Optimizing performance" is what we constantly endeavor to deliver which not only helps us to hunt for the right talent in the market but also nurture a long term affiliation with our esteemed clients.

Job ID: 121913099

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