Manager - Regulatory Affairs

Pay not stated8–10 yrsFull-time

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About the role

We have immediate openings for “Manager – Regulatory Affairs” one of our Reputed Client for Hosur location.

Preparation & Review of drug master file/ Common Technical Document of various Drug substances
Preparation and submission of Technical Packages/ Product Dossiers
Preparation of Declaration of Access and Letter of Access, Letter of Commitment, Letter of Engagement, Submission Letter
Handling of deficiencies from the regulatory agencies as well from customers
Preparation and submission of Quality Questionnaires and related documents receive form customers

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