Global Head of Product Development Regulatory

The Position The Opportunity

The Global Head of PD Regulatory is a visionary executive responsible for steering a bold, distinctive, and data-first organization. This role demands an individual who can make rapid, data-driven strategic decisions as the global landscape evolves, ensuring that the company’s drug and device portfolio is developed effectively and efficiently.

As a recognized authority and thought leader, you will apply the VACC (Visionary, Architect, Coach, Catalyst) leadership principles to inspire a community that transcends traditional compliance, turning regulatory strategy into a primary driver of R&D productivity and patient impact.

• Strategic Oversight: Lead the PD Regulatory department to ensure all global filings and approvals meet or exceed corporate, divisional, and team goals.
• Pathway Innovation: Drive the adoption of novel, non-traditional regulatory pathways (e.g., RWE-based approvals and complex innovative designs). Ensure the organization is not just complying with existing routes but is actively defining the "new normal" for accelerated patient access in high-unmet-need areas.
• Lifecycle Management: Ensure continued support across the entire product lifecycle, from First in Human to withdrawal from the market.
• Research Integration: Provide necessary support for early research and development organizations (such as pRED and gRED) and established product teams.

• Regulatory Diplomacy & Advocacy: Act as a primary architect of the global regulatory environment; proactively lead industry-wide efforts to co-create modernized frameworks and guidances (e.g., ICH, CIOMS) that align with the future of drug development. Leverage strategic influence to dismantle systemic regulatory barriers, converting "headwinds" into competitive advantages that accelerate the delivery of transformative medicines.
• Agency Relations: Establish and maintain relationships with key stakeholders, external opinion leaders, and government health authorities (FDA, EMA, PMDA, NMPA).
• Internal
  
  Collaboration:
  
  Chair the OnePDR Leadership Team and ensure strong collaboration with technical regulatory leadership (PTRLT), affiliates, and Pharma International (DRAs).
• Communication: Strong team player and communicator

• Infrastructure Leadership: Build and maintain an industry-leading regulatory systems infrastructure that serves as the backbone for global operations in partnership with RDT and PTR
• Digital Pivot: Lead the high-stakes transition from traditional, document-centric submissions to an integrated, cloud-based data ecosystem. Champion a "data-as-a-service" mindset, ensuring the organization is the industry leader in Structured Data Submissions and real-time, transparent data exchange with global health authorities.
• Data-Centricity: Drive the adoption of "data-first" strategies, ensuring the organization is prepared for the transition toward Structured Data Submissions and real-time data sharing with health authorities.
• Interoperability: Architect a digital ecosystem that ensures seamless integration between internal R&D data lakes and external regulatory portals.

• Talent Development: Foster a culture of continuous learning, enabling individuals to take ownership of their professional and personal development.
• Agile Network: Partner with the community to build an agile network of empowered individuals and foster an environment of trust.
• Resource Management: Manage the global budget including internal headcount and externalized workforce drive for efficiencies and optimizing resource allocation between internal staff and external partners.

• Education: Advanced degree in a scientific or technical discipline (MS, PhD, MD, Pharm
  
  D).
• Global
  
  Experience:
  
  Significant years of experience in the pharmaceutical industry, with a proven track record in a global role with deep understanding of global drug development.
• Regulatory Expertise: Demonstrable senior leadership experience specifically in Regulatory Affairs including strategy…