Associate I– Reg CMC Strategy (LEC Team)

JOBSUMMARY

Functions as a Strategist for Brands-LEC team, working with Global Regulatory Strategist (GRS-CMC) and CrossFunctionalTeamstoprepareandsubmitthevariationsforentitynamechangeacrossglobalmarkets including US, EU & ROW as per defined timelines.

JOBRESPONSIBILITIES

·      Managesday-to-dayregulatoryactivitiesassociatedwithassignedLECvariationswithinagreed upon timelines.

·      Evaluate changecontrolsforcompleteness,accuracy andrequiredsupporting documents.Initiate change controls when needed.

·      PerformsMarketImpactAssessment(MIA)forthespecificentitynamechange.

·      RunstheRegAtlastodeterminethefilingactionandimpactedsections specific for entity name change and to obtain confirmation from the Regional Regulatory Lead.

·      SearchRegulatorydatabasesforCommonTechnicalDocumentcomponentsorrequest themfrom appropriate market contacts, when not available.

·      FamiliaritywithglobalguidelinesforfilingLegalEntityChanges(LEC)andruncorrespondingreports in the regulatory requirements database.

·      Shouldbe familiarwithsubmissiongroupingpractices.

·      Interpretandapplyglobal/regionalCMCregulatorypolicies.

·      Requestdocumentsfromthe sites/markets/centerfunctionsasneeded.

·      RequestAncillarydocumentsfromAncillarydocumentsteam.

·      Communicatewithmarketsifclarification/prioritizationisneeded.

·      Followupwithallresponsibledisciplinestobeabletomeettimelines.

·      AuthoringoftheimpactedCMCsectionsi.e.Module3undertheguidancefromtheproduct strategistsas appropriate and within agreed timelines.

·      ResponsibleforobtainingapprovalinReg-459formfromGRS CMCsonthecompletionofauthoring the sections.

·      UtilizesPfizer’s CMCsystems, i.e.GDMS,PDM,SPA, PEARL, RegAtlas, Rosetta etc.,as appropriate.

·      Works under the supervision of line manager

·      EnsurescompliancetoPfizerinternalproceduresandtraining SOPs.

. Any other requests as assigned by line managers

QUALIFICATIONS/SKILLS

PreferredEducation:

Minimum–PostgraduateinPharmacy

PreferredExperience:

0-1 yearinleadingindependentlyintheRegulatory Sciencesfunctionina reputedPharmaceuticalOrganization.KnowledgeofNDAs,ANDAs,MAAs,CTDsandother regulatory components.

PreferredAttributes:

Excellent oralandwrittenEnglish communicationskills.Goodconceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile, prioritization of projects with minimum guidance. Attention to detail and accuracy required.

TechnicalSkills:

Regulatoryrequirementsofpostapprovalchanges forUS,EUandROWmarkets.

OralSolidDosageformandsterileinjectablemanufacturingandregulatorydatarequirementsfor post approval submissions.

Knowledgeinretrievinginformationfromcompany’sandregulatory agencydatabases.

Basiclevelofknowledgeongeneralstandards,processes,regulatoryguidancesandpoliciesof Pfizer/Pharmaceutical manufacturing Industry.

Remainknowledgeableaboutcurrentregulationsandguidance,interpretandnotifiesappropriate personnel.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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