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Manager_Regulatory Affairs

6.00 to 11.00 Years   Chennai   18 May, 2022
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaFinance / Accounts / TaxGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Functions as the GRS-CMC to perform some or all of the following activities (by self or under supervision) to identify, assess and remediate potential gaps in conformance between manufacturing documents, the central source dossier and in-market dossiers, across the HBU legacy Hospira Sterile Injectable portfolioSource Dossier BuildMarket AssessmentGlobal Assessment ReviewsGap ClassificationRemediation PlanningRemediation ExecutionSource Dossier Build: Assemble source dossier by validating in-scope sub-sections of reference dossier against corresponding current manufacturing site documents.Market Assessment: Compare in-market approved dossiers to source dossiers and record any potential gaps in conformance.Global Assessment Review & Gap Classification: Assist GRL to review, confirm and classify gaps reported across all markets globally and assist compilation of Gap Classification slide decks to gain Global Assessment Review Chairs approval for planned remediation approach.Remediation Planning: Effective coordination with the GRL/RRL/CRLs, and extend support as needed towards preparation, review and finalization of Global Regulatory Strategy Documents (GRSDs).Remediation Execution: Author required CTD sections for filing of supplements /variations, ensuring effective data presentation and quality, as per the finalized GRSD.Provides technical guidance to colleagues, perform reviews of submission outputs and guide newly inducted colleagues in DC team on Pfizer systems, SOPs, guidances, job aids, etc., as allotted by the Team Lead.Responsible for effective review and providing timely feedback to the GRL/RRL/CRL on technical documents (on a need basis).Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management, Team lead and core team.Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects.Responsible for ensuring compliance to Companys submission standards, policies and procedures.Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs#LI-PFE,

Keyskills :
Business ServicesNew Business OpportunitiesFuture TrendsExit StrategiesBusiness RelationsIdentity Theft ShieldBusiness BrokerageSelling Businesses

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