Enter a job title or keyword
VP Head, Site & Regional, Regulatory CMC – India.
Job Location:
Monthly Salary:
Posted:
29 September 2026 (27 days ago)
Posted:
Application Deadline:
27 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
OBJECTIVES/PURPOSE:
TheindividualinthisroleservesastheenterpriseleaderaccountablefortransformingandintegratingSiteCMCRegionalCMCRegulatoryConformanceandIndiaRegulatoryCMCOperationsintoaunifiedglobaloperatingmodel.TheroleisresponsibleforenablingcompliantefficientandscalablelifecyclemanagementstrengtheningenterpriseresilienceadvancingregulatoryinnovationandestablishingIndiaasaworld-classstrategichubforRegulatoryCMCexcellence.
- DefineandexecutethevisionstrategyandoperatingmodelforSiteCMCRegionalCMCRegulatoryConformanceandIndiaRegulatoryCMCOperations.
- EmbedregulatoryconformancewithinsiteoperationsestablishabiologicsRegulatoryCMCcapabilityformarketedproductsinIndiaandcreateCentersofExcellencethatdrivestandardizationsimplificationoperationalexcellenceanddigitaltransformationacrosstheRegulatoryCMCorganization.
- Ensureconsistentcompliantandscalableexecutionenabledthroughautomationandadvancedtechnologies.
- PositionIndiaasastrategicglobalcapabilitycenterforRegulatoryCMCleveragingexceptionaltalentprocessexcellencedigitalinnovationandfit-for-purposegovernancetodeliverlifecyclemanagementpost-approvalexecutionandregulatoryoperationsatscalewhilesupportingenterprisegrowthandportfolioexpansion.
- Strengthenenterpriseregulatoryresilienceandcompliancethrough science- and risk-based decision-making proactive regulatoryconformanceinspectionreadinessandclearaccountabilityacrossglobalregionallocalandsiteinterfaces.Fosteracultureofqualitycomplianceandcontinuousimprovementthatenablessustainableandpredictableexecutionacrossthenetwork.
- Leadlarge-scaleorganizationaltransformationandcapabilitydevelopment including organization design transition planning stabilizationtalentacquisitionsuccessionplanningleadershipdevelopmentandcontinuousoptimization.Ensuretheorganizationremainsagilefuture-readyandresponsivetoevolvingbusinessprioritiesportfoliocomplexitytechnologicaladvancesandregulatoryexpectations.
- RepresentGlobalRegulatoryAffairsandCMConenterprisegovernanceandportfolioleadershipforumsinfluencingstrategicdecisionsandshapingregulatoryapproachesandfutureinnovationareaswhereregulatoryparadigmscontinuetoevolve.
- Buildandsustainaworld-classorganization empowering senior leaders to attract develop andretaintop talent while fostering a culture ofaccountabilityinclusioninnovationandoperationalexcellence.
ACCOUNTABILITIES
- ModelTakedaleadershipprinciplesandbuildahigh-performinginclusivecompliantandaccountableorganizationthatfosterscollaborationinnovationtalentdevelopmentandacultureofcontinuousimprovementacrossaglobalmatrixenvironment.
- DefineandoverseetheoperatingmodelgovernanceframeworkandprioritiesforSiteCMCRegionalCMCIndiaOperationsandRegulatoryConformanceensuringalignmentwithGRACMCobjectivesandbroaderbusinessgoalswhiledrivingsimplificationconsistencyandscalabilityacrosstheorganization.
- EstablishandscaleIndiaasastrategicglobalcapabilityhubforRegulatoryCMCleveragingorganizationaldesignworkforceplanningprocessexcellenceautomationanddigitalinnovationtodeliversustainablelifecyclemanagementandpost-approvalexecutionatscale.
- Driveenterprise-widestandardizationandoperationalexcellencebygoverningharmonizedprocessesfit-for-purposegovernanceandcross-functionalwaysofworkingacrossSiteCMCRegionalCMCIndiaOperationsGRACMCQualityManufacturingandLocalOperatingCompanyregulatoryorganizations.
- Ensureregulatoryconformancelifecyclecomplianceenterpriseresilienceandinspectionreadinessacrosstheglobalproductportfoliothroughscience-andrisk-baseddecision-makingproactiveissuemanagementandclearaccountabilityacrossglobalregionallocalandsiteinterfaces.
- InpartnershipwiththeleadershipteamestablishandexpandIndia-basedCentersofExcellencethat deliver standardized repeatable and specialized Regulatory CMC capabilities including annual reports renewals WCB/MCBchangesreferencestandardandpharmacopeialupdatesFURLSlistingsIND/IMPDsupportandotherpost-approvallifecyclemanagementactivitieswhilecontinuouslyidentifyingopportunitiesforautomationsimplificationandefficiencygain
- ServeasakeyenterprisethoughtpartnerforRegulatoryAffairsandCMCrepresentingthefunctionacrossgovernanceinnovationandportfolioleadershipforumswhileadvancingregulatorystrategiesthatacceleratetheadoptionofbreakthroughtechnologiesandnovelproductmodalities.Shapetheorganizationspreparednessforfuturescientificadvancementsbyproactivelyaddressingevolvingregulatoryexpectationsandinfluencingindustrybestpractices.
- Developaworld-classRegulatoryCMCleadershiporganization empowering senior leaders to attract develop andretainexceptional talent while cultivating deep technicalexpertise strategic thinking and externalinfluence.
- Leaddevelopandinspireaseniorleadershipteamincludingsuccessionplanstalentstrategiesandperformanceexpectationstoensureorgeffectivenessandastrongtalentpipeline.
- Lead strategic transition and internalization programs including selected complex product support and post-approval project management activities while protecting business continuity and criticalknow-how.
- Serve as the senior enterprise interface for the function influencing governance forums and ensuring effective oversight of performance risk resource prioritization and continuous improvement.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Recognizedexpertisein global CMC regulatory strategy and requirements across the product lifecycle withdeepunderstanding of post-approval submissions lifecycle management and regulatory conformance.
- Broad enterprise understanding of dossier content manufacturing and quality interfaces regulatory documentation and execution models across site regional and local organizations.
- Demonstrated ability to standardize centralize and digitally enable repeatable lifecycleactivities atglobal scale whilemaintainingquality and compliance.
- Experienceestablishingscience- and risk-based assessment frameworks governance models and operating standards in complex global environments.
Leadership
- Leads large complex matrixed global organizations through transformation capability build scale-up and operating model change.
- Creates enterprise clarity on strategyaccountabilities decision rights success measures and leadership expectations.
- Develops senior talent and organizational bench strength through coaching succession planning and differentiated development opportunities.
- Communicates with executive presence simplifies complexity and influences senior stakeholders across functions regions and governance forums.
- The individual will need to manage ambiguity and should have the ability to lead and guide the teams in situations of high stress where the stakes are high. He/she will need to lead the team and manage change while notimpactingcurrent work and timelines. The ability to assess situations and resolve them using risk-based approaches would be a critical attribute.
Decision-making and Autonomy
- Sets enterprise frameworks decision rights and governance expectations for Site CMC RegionalCMC India Operations and Regulatory Conformance.
- Ownsaligning decisions with global regulatory strategy quality expectations business priorities and portfolio risk.
- Makes complex risk-based decisions that balance compliance speed operational resilience resource constraints and long-term capability building.
- Determinesorganizational priorities resourcing trade-offs and escalation pathwaysto sustain delivery across a broad and evolving global scope.
Interaction
- Acts as the senior enterprise interface across Global RA CMC Site CMC Regional CMC India Operations Quality Manufacturing LOC regulatory organizations and other global stakeholders.
- Builds strategic partnerships and reinforces role clarity across interfacing functions to enable seamless post-approval change execution and lifecycle management.
- Communicates complex regulatory organizational and operational matters clearly to executive audiences and senior governance bodies.
- Representsthe function in senior leadership forums and influences enterprise decisions across a broad stakeholder landscape.
- Ability to communicate concisely and clearly across all levels of theorganizationincluding stakeholders in R&DGSQand Commercial. Ability to take complex issues and communicate them ina simple and understandable manner.
Innovation
- Advances regulatory operations through automation digital enablement scalable Centers of Excellence and data-informed performance management.
- Champions simplification standardization and continuous improvement to enhance quality speed compliance transparency and business agility.
- Promotes a culture of proactive planning knowledge sharing operational excellence and responsible innovation across the organization.
Complexity
- Operates ina highly complexglobal environment with interdependencies across manufacturing sites regional and local regulatory organizations quality manufacturing development and commercial partners.
- Leads organizational build transition stabilization and optimization whilemaintainingdelivery across ongoing lifecycle commitments and regulatory obligations.
- Balances capability internalization process harmonization conformance oversight digital enablement and execution at scale across a diverse global portfolio.
- Manages complexity associated with diverse product modalities market-specific regulatory requirements organizational change and cross-cultural ways of working.
EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
- Advanced degree or PhD in life sciences pharmacy medicine or a related discipline.
- 15-20 years of experience in the pharmaceutical industry and/or regulatory agencies including substantial executive leadership experience in Regulatory CMC regulatory sciences or closely related global functions.
- Deep knowledge of global regulatory frameworks and expectations including FDA EMA PMDA NMPA and other major health authorities.
- Extensive expertise in post-approval lifecycle management regulatory conformance manufacturing and quality interfaces and global CMC execution models.
- Demonstrated success leading change operating model evolution and operational excellence in complex matrix environments.
- Strong communication influencing negotiation problem-solving and stakeholder management skills with the ability to align senior leaders and drive enterprise outcomes.
- High organizational awareness and business acumen including understanding of cross-functional interdependencies governance expectations portfolio priorities and regulatory risk.
- Fluent in English both written and verbal; additional languages are desirable.
Locations
IND - Bengaluru - Research and DevelopmentWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeRequired Experience:
Exec
About Company
Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
