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RO
Roche
7d ago

Global Head of Product Development Regulatory(m/w/x)

Basel
Full-timeOn-siteSenior
AI/ML

Description

As a visionary executive, you will redefine global drug approvals by leading a data-first regulatory organization and architecting modern frameworks to accelerate patient access to medicines.

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Requirements

  • Advanced degree in scientific or technical discipline
  • Significant pharmaceutical industry and global drug development experience
  • Senior leadership experience in Regulatory Affairs
  • Experience with global Health Authorities and product approvals
  • Resilience leading through high-stakes regulatory crises
  • Experience scaling AI-driven automation and machine learning
  • Extensive experience leading talent within VACC/RISE framework
  • Innovative Regulatory leadership and technical competence
  • Ability to lead as Visionary, Architect, Coach, Catalyst
  • Strategic agility in situations of ambiguity
  • Sophisticated negotiation skills with health authorities
  • Commitment to patient safety and medical compliance
  • Excellent written and verbal English communication skills

Education

Master's degree

Work Experience

approx. 4 - 6 years

Tasks

  • Lead the global PD Regulatory department
  • Drive adoption of non-traditional regulatory pathways
  • Manage the entire product lifecycle
  • Support early research and development teams
  • Lead industry-wide efforts to modernize frameworks
  • Influence global regulatory policy and advocacy
  • Maintain relationships with major health authorities
  • Chair the OnePDR Leadership Team
  • Collaborate with technical and international affiliates
  • Build industry-leading regulatory systems infrastructure
  • Transition to cloud-based data ecosystems
  • Implement structured data submission strategies
  • Architect integrated digital R&D ecosystems
  • Foster a culture of continuous learning
  • Build an agile network of empowered individuals
  • Manage global budgets and resource allocation

Tools & Technologies

AI-driven automationMachine learningVACC/RISE framework

Languages

EnglishBusiness Fluent

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