Regulatory Affairs- US market

3.00 to 5.00 Years Hyderabad 04 Mar, 2021

Job Location	Hyderabad
Education	Not Mentioned
Salary	Not Disclosed
Industry	Pharma / Biotech
Functional Area	Sales / BD
EmploymentType	Full-time

Job Description

Roles and Responsibilities

US market including post approval and labelling.
Complete understanding of USFDA and ICH requirements.
Responsible for preparation, review and compilation of the dossiers in CTD/eCTD.
Responding to the queries within the timelines as defined by USFDA.
Monitoring of timely submission of Labelling Initials, Amendments, Labelling Supplements and Annual Reports.
Responsible for life-cycle management of regulatory submissions.
Responsible for preparation and maintenance of all the documents related to the regulatory submissions.
Coordinate and supports all concerned departments with respect to the required documents for submission purpose.
Review of Product Development Report, Protocols, Batch Records, Specifications and STP etc.
Good written and oral communication

Keyskills :
protocolsrecordsregulatorypreparationproduct developmentmanagementspecificationsichoral communicationmilestonesmaintenanceusfdabatch recordsstpcapasbatch releasecompilationsupplementscommunicationbatch control

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Regulatory Affairs- US market

Job Description

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