Director - Global Regulatory Affairs CMC

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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.

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