Major accountabilities:

• Team Leadership:
  • Lead a diverse global team to ensure alignment with organizational goals and business priorities related to Submissions and Registration Management
  • Define and communicate the strategic vision for Submission and Registration Management capabilities, fostering a culture of excellence and continuous improvement.
  • Regularly assess team performance against established metrics and objectives. Provide feedback, recognize achievements, and address areas for improvement through coaching and development opportunities.
• Promote a collaborative and inclusive work environment, where team members are empowered to contribute to their full potential.
• Roadmap Development:
  • Define, prioritize, and deploy an integrated platform roadmap in collaboration with RA D&T LT, relevant stakeholders, and DDIT partners, ensuring alignment with the Development and Enterprise technology strategy roadmaps.
• Stakeholder engagement:
  • Represent the platform in digital governance boards and leadership meetings across the organization
  • Represent the platform in digital networks, externally (e.g. across Industries) as needed
  • Communicate effectively to ensure understanding and support for new technology initiatives. 
  • Support continuous expansion of knowledge and foster the adoption of a digital mindset within Regulatory Affairs.
• Collaboration and Partnerships:
  • Build and maintain collaborative and productive partnerships across the Platform team and enterprise stakeholders to achieve business priorities.
  • Oversee vendors at the Platform level, in collaboration with IT and External Partnership Teams
• Quality and Compliance:
  • Ensure on-time, compliant, secure, and quality delivery of portfolio for the assigned capabilities, aligned with the NVS Quality Manual.
  • Contribute to the change management strategy to ensure smooth adoption of technology initiatives, as required
  • Ensure adherence to Security and Compliance policies and procedures within the scope of the Platform, and prepare for audit readiness and inspection requirements (incl. Related mitigations or actions triggered by audits & inspections).
• Project and Program Support:
  • Provide support and resources for key projects and programs impacting the underlying capabilities to ensure timely delivery of high-quality milestones that align with business requirements. 
  • Collaborate with business, IT, and other stakeholders to develop and define project scope, objectives, and interdependencies for projects.
• Demand Management:
  • Effectively manage demands for technology services and operational support arising from various functions within Regulatory Affairs.
  • Ensure monitoring of overall service delivery performance and backlog.
• Industry Trends:
• Stay updated with industry trends and emerging practices to drive agility, speed, efficiency, and effectiveness within the team.
• Accountable for release management processes to ensure timely and coordinated delivery of software updates and system enhancements across global platforms.
• Accountable for the establishment of validation frameworks/standards for essential system platforms and applications to ensure compliance with regulatory and industry standards within the life sciences sector.
• Accountable for the establishment of migration frameworks/standards and the managing/executing of migration projects, ensuring a seamless transition and integration of new Systems, Data and Applications with minimal disruption to business.
• Accountable for the establishment of Business Administration frameworks/standards and implementation for the management of RA technology programs, focusing on efficiency and effectiveness.
• Platform operation capabilities

Key performance indicators:

• Achieve key Regulatory Affairs business objectives and stakeholder milestones by leading the Platform, ensuring adequate resourcing  for timely delivery and continuous operations of the RA Data & Technology roadmap.
• Implement operational frameworks for release management, validation, migration and business operations supporting the quick adoption of harmonized, scalable, enterprise solutions delivered and bringing benefits to the full organization and allowing us to be state of the art and ready for future needs.
• Ensure RA Technology & Platforms operational execution through high availability of systems, smooth migration, validation and release deployment and efficient business administration of the landscape
• No critical audit finding and inspections related to migration, validation, release management, security or business administration

Minimum Requirements:

Education:

Bachelor’s degree: master’s or commensurate experience. Advanced degree in life science, pharmaceutical, technology, or data science preferred
Work Experience and Skills:

• 8+ years of industry experience
• Matrix / cross-functional leadership experience preferred
• Strong understanding and direct relevant experience with the technology landscape operations of pharmaceutical regulatory affairs
• Strong strategic problem-solving skills and ability to navigate un-charted territory without clear precedent
• Experience presenting/speaking at a senior management level with a proven track record of effectively communicating complex initiatives
• Strong global leadership skills demonstrated by a proven track record of successfully managing people, technology initiatives and/or leading groups or teams, inspiring innovative, strategic and big picture thinking.
• Demonstrated leadership in driving risk assessment and mitigation, clear strategic thinking, prioritization, maintaining awareness of global patient and business impact.
• Strong negotiation skills
• Excellent verbal and written communications
• Strong experience in technology process requirements migration, release management, and validation/testing including audit and knowledge of regulatory requirements

Languages :

• English.