At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

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.

Key Responsibilities

1. Global Regulatory Strategy & Filings

• 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.

2. External Influence & Stakeholder Engagement

• 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

3. Systems and Digitalization Excellence

• 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.

4. Organizational Excellence & Culture

• 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.

Qualifications & Experience

• Education: Advanced degree in a scientific or technical discipline (MS, PhD, MD, PharmD).
• Global Experience: Significant years of experience in the pharmaceutical industry, with a proven track record in success in a global role with deep understanding of global drug development
• Regulatory Expertise: Demonstrable senior leadership experience specifically in Regulatory Affairs including strategy and/or policy.
• Track Record: Demonstrated experience interacting directly with global Health Authorities (FDA, EMA, NMPA or PMDA) and proven success in leading multiple global product approvals (NDA/BLA/MAA) and navigating complex therapeutic areas.
• Proven Resilience: Leading global organizations through high-stakes regulatory crises, major safety signals, or rapid shifts in the geopolitical regulatory landscape.
• Digital transformation: Evidence of initiating and successfully scaling AI-driven automation and machine learning within a global regulatory function to increase speed, efficiencies and maintaining high quality.
• Leadership: Extensive experience leading and developing talent through training, mentoring, and coaching within a VACC/RISE framework .

Core Competencies

• Proven track record of innovative Regulatory leadership, technical competence and business impact
• VACC Leadership: Ability to lead as a Visionary, Architect, Coach, and Catalyst to drive innovation.
• Strategic Agility: Ability to assimilate complex information to inform decisions and make effective proposals in situations of ambiguity.
• Negotiation Skills: High level of sophistication in managing delicate negotiations with health authorities and external partners.
• Integrity & Compliance: Unwavering commitment to patient safety, medical compliance, and the Group Code of Conduct.
• Communication: Excellent written and verbal communication skills in English.

Note: Succession talents have been identified, however we welcome applications from candidates who feel they meet/exceed the above-outlined criteria.

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.