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

Overview

Enterprise leader accountable for transforming and integrating Site CMC, Regional CMC, Regulatory Conformance, and India Regulatory CMC Operations into a unified global operating model, and establishing India as a strategic hub for Regulatory CMC excellence.

What you'll do

• 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 and establish a biologics Regulatory CMC capability for marketed products in India.
• Create Centers of Excellence that drive standardization, simplification, operational excellence, and digital transformation across the Regulatory CMC organization.
• Position India as a strategic global capability center for Regulatory CMC, delivering lifecycle management, post-approval execution, and regulatory operations at scale.
• Strengthen enterprise regulatory resilience and compliance through science- and risk-based decision-making, proactive regulatory conformance, and inspection readiness.
• Lead large-scale organizational transformation and capability development, including organization design, transition planning, stabilization, talent acquisition, succession planning, and leadership development.
• Represent Global Regulatory Affairs and CMC on enterprise governance and portfolio leadership forums.
• Build and sustain a world-class organization, empowering senior leaders to attract, develop, and retain top talent.
• Govern 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.
• In partnership with leadership, establish India-based Centers of Excellence covering annual reports, renewals, WCB/MCB changes, reference standard and pharmacopeial updates, FURLS listings, IND/IMPD support, and other post-approval lifecycle activities.
• Lead strategic transition and internalization programs, including selected complex product support and post-approval project management, while protecting business continuity and critical know-how.

What you'll need

• Recognized expertise in global CMC regulatory strategy and requirements across the product lifecycle, including post-approval submissions, lifecycle management, and regulatory conformance.
• Broad 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.
• Experience leading large, complex, matrixed global organizations through transformation, capability build, scale-up, and operating model change.
• Ability to manage ambiguity and lead teams in high-stress, high-stakes situations while managing change without impacting current work and timelines.
• Fluent in English, both written and verbal.

Nice to have

• 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, 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.
• High organizational awareness and business acumen.
• Additional languages.

Details

• Location: IND - Bengaluru - Research and Development.
• Worker type: Employee; sub-type: Regular.
• Time type: Full time.