Associate I– Reg CMC Strategy (LEC Team)

Bioksha; Chennai District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Pfizer seeks a Regulatory Affairs professional to act as Strategist for Brands-LEC, coordinating with the Global Regulatory Strategist (GRS-CMC) and Cross-Functional Teams to prepare and submit variations for entity name changes across US, EU, and ROW within defined timelines.

The role covers day-to-day regulatory activities, change controls, market impact assessments, and alignment with Pfizer procedures and regional guidelines, under supervision of the line manager.

Qualifications

• Minimum–Postgraduate in Pharmacy.
• 0–1 year in Regulatory Sciences in a pharma setting.
• Knowledge of NDAs, ANDAs, MAAs, CTDs.
• Excellent oral and written English communication.

Responsibilities

• Manages day-to-day regulatory activities for assigned LEC variations within timelines.
• Evaluate change controls for completeness, accuracy and supporting documents.
• Performs Market Impact Assessment for entity name changes.
• Run the RegAtlas to determine filing actions and confirm with Regional Regulatory Lead.
• Familiarity with global guidelines for filing LECs and run corresponding reports.
• Interpret and apply global/regional CMC regulatory policies.
• Request documents from sites/markets as needed and communicate with markets.
• Authoring of impacted CMC sections under guidance and obtain Reg-459 approvals.

Skills

Regulatory knowledge

English communication

Analytical skills

Organizational skills

Prioritization

Attention to detail

Problem solving

Education

Postgraduate in Pharmacy

Tools

GDMS

PDM

SPA

PEARL

RegAtlas

Rosetta

Job description

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

PreferredEducation

Minimum–PostgraduateinPharmacy

PreferredExperience

0-1 yearinleadingindependentlyintheRegulatory Sciencesfunctionina reputedPharmaceutical Organization.

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, EU andROWmarkets.
• 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