Pfizer Hiring 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 change controls for completeness, accuracy and required supporting documents. Initiate change controls when needed.
· Performs Market Impact Assessment(MIA)for thespecificentitynamechange.
· 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–Postgraduate in Pharmacy
Preferred Experience:
0-1 year in leading in dependently in the Regulatory Sciences function in a reputedPharmaceuticalOrganization.KnowledgeofNDAs,ANDAs,MAAs,CTDsandother regulatory components.
Preferred Attributes:
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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