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VP Head, Site & Regional, Regulatory CMC – India.

応募 後で応募 求人ID R0189733 掲載日 09/16/2026 Location:Bengaluru, India

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Job Description

OBJECTIVES/PURPOSE:

TheindividualinthisroleservesastheenterpriseleaderaccountablefortransformingandintegratingSiteCMC,RegionalCMC,RegulatoryConformance,andIndiaRegulatoryCMCOperationsintoaunifiedglobaloperatingmodel.Theroleisresponsibleforenablingcompliant,efficient,andscalablelifecyclemanagement,strengtheningenterpriseresilience,advancingregulatoryinnovation,andestablishingIndiaasaworld-classstrategichubforRegulatoryCMCexcellence.

  • Defineandexecutethevision,strategy,andoperatingmodelforSiteCMC,RegionalCMC,RegulatoryConformance,andIndiaRegulatoryCMCOperations.
  • Embedregulatoryconformancewithinsiteoperations,establishabiologicsRegulatoryCMCcapabilityformarketedproductsinIndia,andcreateCentersofExcellencethatdrivestandardization,simplification,operationalexcellence,anddigitaltransformationacrosstheRegulatoryCMCorganization.
  • Ensureconsistent,compliant,andscalableexecutionenabledthroughautomationandadvancedtechnologies.
  • PositionIndiaasastrategicglobalcapabilitycenterforRegulatoryCMC,leveragingexceptionaltalent,processexcellence,digitalinnovation,andfit-for-purposegovernancetodeliverlifecyclemanagement,post-approvalexecution,andregulatoryoperationsatscalewhilesupportingenterprisegrowthandportfolioexpansion.
  • Strengthenenterpriseregulatoryresilienceandcompliancethrough science- and risk-based decision-making, proactive regulatoryconformance,inspectionreadiness,andclearaccountabilityacrossglobal,regional,local,andsiteinterfaces.Fosteracultureofquality,compliance,andcontinuousimprovementthatenablessustainableandpredictableexecutionacrossthenetwork.
  • Leadlarge-scaleorganizationaltransformationandcapabilitydevelopment, including organization design, transition planning, stabilization,talentacquisition,successionplanning,leadershipdevelopment,andcontinuousoptimization.Ensuretheorganizationremainsagile,future-ready,andresponsivetoevolvingbusinesspriorities,portfoliocomplexity,technologicaladvances,andregulatoryexpectations.
  • RepresentGlobalRegulatoryAffairsandCMConenterprisegovernanceandportfolioleadershipforums,influencingstrategicdecisionsandshapingregulatoryapproachesandfutureinnovationareaswhereregulatoryparadigmscontinuetoevolve.
  • Buildandsustainaworld-classorganization, empowering senior leaders to attract, develop, andretaintop talent while fostering a culture ofaccountability,inclusion,innovation,andoperationalexcellence.

ACCOUNTABILITIES

  • ModelTakedaleadershipprinciplesandbuildahigh-performing,inclusive,compliant,andaccountableorganizationthatfosterscollaboration,innovation,talentdevelopment,andacultureofcontinuousimprovementacrossaglobalmatrixenvironment.
  • Defineandoverseetheoperatingmodel,governanceframework,andprioritiesforSiteCMC,RegionalCMC,IndiaOperations,andRegulatoryConformance,ensuringalignmentwithGRACMCobjectivesandbroaderbusinessgoalswhiledrivingsimplification,consistency,andscalabilityacrosstheorganization.
  • EstablishandscaleIndiaasastrategicglobalcapabilityhubforRegulatoryCMC,leveragingorganizationaldesign,workforceplanning,processexcellence,automation,anddigitalinnovationtodeliversustainablelifecyclemanagementandpost-approvalexecutionatscale.
  • Driveenterprise-widestandardizationandoperationalexcellencebygoverningharmonizedprocesses,fit-for-purposegovernance,andcross-functionalwaysofworkingacrossSiteCMC,RegionalCMC,IndiaOperations,GRACMC,Quality,Manufacturing,andLocalOperatingCompanyregulatoryorganizations.
  • Ensureregulatoryconformance,lifecyclecompliance,enterpriseresilience,andinspectionreadinessacrosstheglobalproductportfoliothroughscience-andrisk-baseddecision-making,proactiveissuemanagement,andclearaccountabilityacrossglobal,regional,local,andsiteinterfaces.
  • Inpartnershipwiththeleadershipteam,establishandexpandIndia-basedCentersofExcellencethat deliver standardized, repeatable, and specialized Regulatory CMC capabilities, including annual reports, renewals, WCB/MCBchanges,referencestandardandpharmacopeialupdates,FURLSlistings,IND/IMPDsupport,andotherpost-approvallifecyclemanagementactivities,whilecontinuouslyidentifyingopportunitiesforautomation,simplification,andefficiencygain
  • ServeasakeyenterprisethoughtpartnerforRegulatoryAffairsandCMC,representingthefunctionacrossgovernance,innovation,andportfolioleadershipforumswhileadvancingregulatorystrategiesthatacceleratetheadoptionofbreakthroughtechnologiesandnovelproductmodalities.Shapetheorganization'spreparednessforfuturescientificadvancementsbyproactivelyaddressingevolvingregulatoryexpectationsandinfluencingindustrybestpractices.
  • Developaworld-classRegulatoryCMCleadershiporganization, empowering senior leaders to attract, develop, andretainexceptional talent while cultivating deep technicalexpertise, strategic thinking, and externalinfluence.
  • Lead,develop,andinspireaseniorleadershipteam,includingsuccessionplans,talentstrategies,andperformanceexpectationstoensureorgeffectivenessandastrongtalentpipeline.
  • 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 strategy,accountabilities, 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 pathwaysrequiredto 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&D,GSQand 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 Development

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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