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

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Job Description

OBJECTIVES/PURPOSE

The   individual   in   this   role   serves   as   the   enterprise   leader   accountable   for   transforming   and   integrating   Site   CMC,   Regional   CMC,   Regulatory   Conformance,   and   India   Regulatory   CMC   Operations   into   a   unified   global   operating   model.   The   role   is   responsible   for   enabling   compliant,   efficient,   and   scalable   lifecycle   management,   strengthening   enterprise   resilience,   advancing   regulatory   innovation,   and   establishing   India   as   a   world-class   strategic   hub   for   Regulatory   CMC   excellence.

• Define   and   execute   the   vision,   strategy,   and   operating   model   for   Site   CMC,   Regional   CMC,   Regulatory   Conformance,   and   India   Regulatory   CMC   Operations.

• Embed   regulatory   conformance   within   site   operations,   establish   a   biologics   Regulatory   CMC   capability   for   marketed   products   in   India,   and   create   Centers   of   Excellence   that   drive   standardization,   simplification,   operational   excellence,   and   digital   transformation   across   the   Regulatory   CMC   organization.

• E nsure   consistent,   compliant,   and   scalable   execution   enabled   through   automation   and   advanced   technologies.

• Position   India   as   a   strategic   global   capability   center   for   Regulatory   CMC ,   leveraging   exceptional   talent,   process   excellence,   digital   innovation,   and   fit-for-purpose   governance   to   deliver   lifecycle   management,   post-approval   execution,   and   regulatory   operations   at   scale   while   supporting   enterprise   growth   and   portfolio   expansion.

• Strengthen   enterprise   regulatory   resilience   and   compliance   through science- and risk-based decision-making, proactive regulatory   conformance,   inspection   readiness,   and   clear   accountability   across   global,   regional,   local,   and   site   interfaces.   Foster   a   culture   of   quality,   compliance,   and   continuous   improvement   that   enables   sustainable   and   predictable   execution   across   the   network.

• Lead   large-scale   organizational   transformation   and   capability   development , including organization design, transition planning, stabilization,   talent   acquisition,   succession   planning,   leadership   development,   and   continuous   optimization.   Ensure   the   organization   remains   agile,   future-ready,   and   responsive   to   evolving   business   priorities,   portfolio   complexity,   technological   advances,   and   regulatory   expectations.

• Represent   Global   Regulatory   Affairs   and   CMC   on   enterprise   governance   and   portfolio   leadership   forums ,   influencing   strategic   decisions   and   shaping   regulatory   approaches   and   future   innovation   areas   where   regulatory   paradigms   continue   to   evolve.

• Build   and   sustain   a   world-class   organization , empowering senior leaders to attract, develop, and   retain   top talent while fostering a culture of   accountability,   inclusion,   innovation,   and   operational   excellence.

ACCOUNTABILITIES

• Model   Takeda   leadership   principles   and   build   a   high-performing,   inclusive,   compliant,   and   accountable   organization   that   fosters   collaboration,   innovation,   talent   development,   and   a   culture   of   continuous   improvement   across   a   global   matrix   environment.

• Define   and   oversee   the   operating   model,   governance   framework,   and   priorities   for   Site   CMC,   Regional   CMC,   India   Operations,   and   Regulatory   Conformance,   ensuring   alignment   with   GRA   CMC   objectives   and   broader   business   goals   while   driving   simplification,   consistency,   and   scalability   across   the   organization.

• Establish   and   scale   India   as   a   strategic   global   capability   hub   for   Regulatory   CMC ,   leveraging   organizational   design,   workforce   planning,   process   excellence,   automation,   and   digital   innovation   to   deliver   sustainable   lifecycle   management   and   post-approval   execution   at   scale.

• Drive   enterprise-wide   standardization   and   operational   excellence   by   governing   harmonized   processes,   fit-for-purpose   governance,   and   cross-functional   ways   of   working   across   Site   CMC,   Regional   CMC,   India   Operations,   GRA   CMC,   Quality,   Manufacturing,   and   Local   Operating   Company   regulatory   organizations.

• Ensure   regulatory   conformance,   lifecycle   compliance,   enterprise   resilience,   and   inspection   readiness   across   the   global   product   portfolio   through   science-   and   risk-based   decision-making,   proactive   issue   management,   and   clear   accountability   across   global,   regional,   local,   and   site   interfaces.

• In   partnership   with   the   leadership   team,   establish   and   expand   India-based   Centers   of   Excellence   that deliver standardized, repeatable, and specialized Regulatory CMC capabilities, including annual reports, renewals, WCB/MCB   changes,   reference   standard   and   pharmacopeial   updates,   FURLS   listings,   IND/IMPD   support,   and   other   post-approval   lifecycle   management   activities,   while   continuously   identifying   opportunities   for   automation,   simplification,   and   efficiency   gain

• Serve   as   a   key   enterprise   thought   partner   for   Regulatory   Affairs   and   CMC,   representing   the   function   across   governance,   innovation,   and   portfolio   leadership   forums   while   advancing   regulatory   strategies   that   accelerate   the   adoption   of   breakthrough   technologies   and   novel   product   modalities.   Shape   the   organization's   preparedness   for   future   scientific   advancements   by   proactively   addressing   evolving   regulatory   expectations   and   influencing   industry   best   practices.

• Develop   a   world-class   Regulatory   CMC   leadership   organization , empowering senior leaders to attract, develop, and   retain   exceptional talent while cultivating deep technical   expertise , strategic thinking, and external   influence.

• Lead,   develop,   and   inspire   a   senior   leadership   team ,   including   succession   plans,   talent   strategies,   and   performance   expectations   to   ensure   org   effectiveness   and   a   strong   talent   pipeline.

• Lead strategic transition and internalization programs, including selected complex product support and post-approval project management activities, while protecting business continuity and critical   know-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

• Recognized   expertise   in global CMC regulatory strategy and requirements across the product lifecycle, with   deep   understanding 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 lifecycle   activities at   global