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 andrequiredsupporting documents.Initiate change controls when needed.
- PerformsMarketImpactAssessment(MIA)forthespecificentitynamechange.
- RunstheReg Atlastodeterminethefilingactionandimpactedsections 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.
- Requestdocumentsfromthesites/markets/centerfunctionsasneeded.
- RequestAncillarydocumentsfromAncillarydocumentsteam.
- Communicatewithmarketsifclarification/prioritizationisneeded.
- Followupwithallresponsibledisciplinestobeabletomeettimelines.
- AuthoringoftheimpactedCMCsectionsi.e.Module3undertheguidancefromthe product 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.
- MustbeextremelyorganizedasLEC projectscanrunacrossmultipleproducts/markets.
- EnsurescompliancetoPfizerinternalproceduresandtrainingSOPs.
- Ownership of process improvements,



metrics and delivery risks
- Team player and work under matrix environment
- Works under the supervision of line manager
- Escalation management and cross-functional issue resolution.
- Accountability for defined team milestones, rather than only assigned individual activities.
- Technical coaching or knowledge sharing within the work team.
- Takesresponsibilityforaportionoftheworkteam’smilestones/ deliverables.
- Any other requests as assigned by line managers.

Qualifications/Skills

PreferredEducation Minimum–Postgraduate inPharmacy

PreferredExperience

Minimum 7YearsinleadingindependentlyintheRegulatory Sciencesfunctionina reputedPharmaceuticalOrganization.KnowledgeofNDAs,ANDAs,MAAs,CTDsandother regulatory components.

PreferredAttributes

ExcellentoralandwrittenEnglishcommunicationskills.Goodconceptual,analytical,problemsolving, reasoning and organizational skills. Should be change agile, prioritization of projects with minimum guidance. Attention to detail and accuracy required.

TechnicalSkills

Regulatory requirementsofpostapprovalchangesforUS,EUandROWmarkets.

OralSolidDosageformandsterileinjectablemanufacturingandregulatorydatarequirementsfor post approval submissions.

Knowledgeinretrievinginformationfromcompany’sandregulatory agencydatabases.

Advanced levelofknowledgeongeneralstandards,processes,regulatoryguidancesandpoliciesof Pfizer/Pharmaceutical manufacturing Industry.

Remainknowledgeableaboutcurrentregulationsandguidance,interpretsandnotifies appropriate personnel.

Pfizer is an equal chance 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

📌 Associate Manager I - Reg CMC Strategy (LEC Team) (Chennai)
🏢 Bioksha
📍 Chennai