Director Global Regulatory Affairs CMC

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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.