Director - Global Regulatory Affairs CMC

IND - 2025 Takeda Biopharmaceuticals India Private Limited; Karnataka; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

IND - 2025 Takeda Biopharmaceuticals India Private Limited is seeking a senior leader to establish and scale India as a global regulatory capability hub for CMC activities. You will lead the GRA CMC India organization, drive lifecycle management, and enable automated, compliant post-approval execution across the global network.

The role requires deep global CMC/regulatory expertise, experience building Center of Excellence models, and strong leadership to attract and develop top regulatory

Qualifications

• Advanced degree or PhD in life sciences, pharmacy, medicine, or a related discipline.
• 12+ 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.
• Fluent in English, both written and verbal; additional languages are desirable.

Responsibilities

• Lead the Global CMC Regulatory Affairs (GRA CMC) India organization for scalable execution of post-approval regulatory activities.
• Establish and optimize CMC RA Centers of Excellence to deliver high-volume regulatory activities and drive standardization and automation.
• Recruit, develop, and scale biologics regulatory capabilities (ERT and Hematology) and IND-enabling programs.
• Partner with Site, Regional, and Global functions to ensure compliance, efficiency, and alignment with global regulatory strategy.

Skills

Executive leadership

Regulatory CMC

Stakeholder management

Strategic thinking

Change management

Communication skills

Education

Advanced degree or PhD in life sciences

Job description

OBJECTIVES/PURPOSE

The individual in this role is accountable for establishing and scaling India as a critical global regulatory capability center, delivering operational excellence, lifecycle management, regulatory execution, and innovation across the Global CMC Regulatory Affairs organization while building future-ready capabilities that support enterprise growth, portfolio expansion, and regulatory compliance worldwide. Key accountabilities include: Lead the Global CMC Regulatory Affairs (GRA CMC) India organization, supporting Global, Regional, and Site CMC teams to enable scalable, efficient, and compliant execution of post-approval regulatory activities. Leverage India-based capabilities, digital solutions, automation, and standardized processes to enhance operational efficiency, quality, consistency, and predictability across lifecycle management activities. Establish, expand, and continuously optimize CMC RA Centers of Excellence to deliver high-volume regulatory activities, drive process standardization and automation, and foster a culture of continuous improvement. Serve as a strategic partner across Site, Regional, and Global functions to ensure organizational alignment, regulatory compliance, operational excellence, and effective execution of business priorities. Build and develop organizational capabilities to assume Marketed Product CMC Regulatory Affairs product leadership responsibilities and support the evolving needs of the global portfolio. Recruit, develop, and scale biologics regulatory capabilities, initially supporting the Enzyme Replacement Therapy (ERT) and Hematology portfolios, while driving operational excellence to streamline execution, improve responsiveness, and increase organizational efficiency. Recruit, develop and scale capabilities to support IND-enabling and early-stage development programs, including core dossier authoring and management, while driving standardization and reusability of regulatory content to improve quality and efficiency. Maintain deep expertise in global CMC, quality, and regulatory requirements, ensuring proactive interpretation, communication, and implementation of regulatory expectations across stakeholders and functions. Position India as a strategic global capability hub for CMC Regulatory Affairs by leveraging exceptional talent, process excellence, digital innovation, and fit-for-purpose governance to deliver lifecycle management, regulatory operations, and post-approval execution at scale. Foster a culture of quality, compliance, accountability, innovation, and continuous improvement that enables sustainable, predictable, and inspection-ready execution across the global network. Ensure the organization remains agile, future-ready, and responsive to evolving business priorities, portfolio complexity, technological advancements, and changing regulatory landscape. Build and sustain a world-class organization by attracting, developing, engaging, and retaining top talent while promoting an inclusive, high-performance culture focused on growth, collaboration, and operational excellence.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

Deep expertise in global CMC regulatory requirements across the product lifecycle, with emphasis on submissions and lifecycle strategy. Strong understanding of dossier content and regulatory documentation. Experience establishing science- and risk-based regulatory assessment frameworks and standardized approaches.

Leadership

Proven ability to lead and develop high-performing teams in a complex, matrixed environment. Creates clarity on roles, expectations, and success measures while developing talent through stretch assignments and coaching. Strong strategic mindset with the ability to simplify complex issues and translate global strategy into actionable regional execution. Excellent communication and influencing skills across organizational levels. 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. Operates with significant autonomy, 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.

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. Acts as an advocate for automation. Promotes a culture of proactive planning, knowledge sharing, operational excellence, and responsible innovation across the organization.

Complexity

Operates effectively in a highly complex global environment with multiple stakeholders and competing priorities. Manages assignments in an organized, timely manner and proactively communicates changes to goals or deadlines. Balances multiple concurrent priorities related to post-approval lifecycle management and site operations.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

• Advanced degree or PhD in life sciences, pharmacy, medicine, or a related discipline.
• 12+ 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

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you’ll make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.