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.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available onPfizer Careers.

Regulatory Affairs