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

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About This Role:

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.
• Ensure 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.
• 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 enterprisewide 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.

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 scale while maintaining quality and compliance. 

• Experience establishing science- 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 not impacting current 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, Regional CMC, India Operations, and Regulatory Conformance. 

• Owns aligning 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. 

• Determines organizational priorities, resourcing trade-offs, and escalation pathways required to 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. 

• Represents the function in senior leadership forums and influences enterprise decisions across a broad stakeholder landscape. 

• Ability to communicate concisely and clearly across all levels of the organization including stakeholders in R&D, GSQ and Commercial. Ability to take complex issues and communicate them in a 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 in a highly complex global environment with interdependencies across manufacturing sites, regional and local regulatory organizations, quality, manufacturing, development, and commercial partners. 

• Leads organizational build, transition, stabilization, and optimization while maintaining delivery 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. 

• 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.