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Executive Regulatory Affairs

1.00 to 3.00 Years   Vadodara   30 Jan, 2022
Gowrie Healthcare Pvt Ltd No3, BPEstate,OppSitaram SuperMarket, Chhani
Job LocationVadodara
EducationNot Mentioned
SalaryRs 1.5 - 4.0 Lakh/Yr
IndustryPharma / Biotech
Functional AreaCorporate Legal DepartmentSales / BD
EmploymentTypeFull-time

Job Description

    PRIMARY RESPONSIBILITIES:- Responsible for compiling regulatory documents including all Modules for EU regulation.- Reviewing regulatory documents such as manufacturing batch records, packaging batch records, analytical method, validation protocol and reports.- Responsible for coordinating with cross-departmental teams such as Contract Lab and Contract Manufacturer for timely submission if required, collection of documents, review of documents and resolving any regulatory discrepancies.- Keeping up to date with regulatory issues in drug development processes and working to eliminate or minimise regulatory barriers.- Responsible for deficiency reply received from agency.SECONDARY RESPONSIBILITIES:- Maintenance of database with regulatory submission and approval.- Proactively keeping up to date with Regulatory guidance.- To prepare documents for applications, renewals and variations from start to end.ESSENTIAL EXPERIENCE, SKILLS AND ABILITIES:- Good understanding of CMC.- Knowledge of completing a dossier for EU countries through DCP, MRP, National procedures.- Good knowledge of life cycle management of products.- Knowledge of completing a dossier in Niche or eCTD submission.- Clear communication skills both written and verbal. ,

Keyskills :
protocolscompilationvalidationbatch recordsdcprecordsmarketingdatabase

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