Executive Regulatory Affairs Formulation

4.00 to 6.00 Years Mumbai City 13 Jan, 2021

Job Location	Mumbai City
Education	Not Mentioned
Salary	Not Disclosed
Industry	Pharma / Biotech
Functional Area	Sales / BD,Corporate Legal Department
EmploymentType	Full-time

Job Description

Responsibilities-Relevant formulation experience in Regulatory Affairs for US submissions with following expertise

Author high quality CMC documentation for US FDA submissions (Original ANDA/Deficiency responses/Post approval supplements/Annual reports) in accordance with latest guidances assuring technical congruency and regulatory compliance.
Identify the required documentation for US regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
Review and Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues proactively.
Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical tre.
Coordination with stakeholders on a regular basis to extend all technical support required from regulatory perspective.
Actively participate as a member by contributing to the regulatory strategy, identifying critical issues and lessons learned.
Hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle.

Keyskills :
gmpcompilationvalidationprotocolsmarketingtechnical supportregulatory affairsregulatory guidelinesregulatory submissionsusfdalessonssoftwarestrategyauthoringregulatoryformulationdocumentationcmcfdaepublishing

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Job Description

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