Global Director Solution Delivery Regulatory Solutions

The Global Director, Solutions Delivery Regulatory Solutions reports to the Global Head, Regulatory, Patient Safety and Pipeline & Portfolio Solutions. The role is managing service delivery for a business area/sub capability of the company across all geographies. Accountable to Global Business Units for end-to-end project delivery and/or operations in the given sub-domain/sub-capability. Partner with Business Stakeholders (Sandoz RA) and Technology teams for demand analysis, solution proposal/evaluation and project delivery on the strategic RA technology roadmap. The role holder will need to work closely with business owners and stakeholders from Regulatory Affairs related team and lead strategic and transformative projects to improve Sandoz s capability in this focus area, drive successful execution and benefits realization at a global scale.

• Run efficient DevOps during whole lifecycle of platforms, products, or systems from initiation till retirement, ensuring availability and optimal performance for responsible Domain / functions.
• Define and execute technology delivery strategy for business systems, platforms, and processes for responsible business domain/function(s).
• Partner with senior business stakeholders and technology teams for demand analysis, solution proposal/evaluation, and funding estimates.
• Partner with vendors to keep abreast with upgrades, changes and latest technology.
• Ensure on time, within budget, compliant, secure, and quality delivery of portfolio for responsible Business domain / functions.
• Ensure services, solutions, products are fit for purpose and achieve the desired business value and impact.
• Establish governance structure for projects, operations, etc. with right stakeholder representation for responsible Domain / functions.
• Track, report, and deliver against agreed success factors and KPIs for various stakeholders for responsible Domain / functions.
• Follow industry trends and emerging practices to drive agility, speed, efficiency, and effectiveness. Ensure the overall user experience is taken into account when designing deploying new solutions and services.
• Take accountability to ensure adherence to Security and Compliance policies and procedures.
• If required, manage projects/products following Agile and other relevant PM practices.

• Minimum 10 to 12 years industry experience in IT, healthcare, or pharma; expert understanding of technology and methodologies as applied in the respective area.
• Expert knowledge of Regulatory Affairs business processes and complexities
• Strong experience implementing and managing IT technologies supporting key business capabilities, incl. Submission / Document Management, Regulatory Information Management, Labelling, etc.
• Multi-national global experience
• Experience in leading products and managing diverse group of stakeholders.
• Experience and understanding of Agile product development.
• Deep knowledge of IT & business processes and experience in validated environments (GxP)
• Ability to communicate effectively with senior management, manage issues, resolve conflicts, and mitigate risks.

• Strong Veeva Vault RIM (Registrations, Submissions, etc.) / Lorenz docuBridge knowledge and experience considered a plus.
• Excellent communication & presentation skills
• Networking with key business and IT stakeholders and ability to present to senior stakeholder groups.
• Strong teamwork and interpersonal skills at team and management levels, with the ability to establish and maintain a high level of trust and confidence.
• Excellent negotiation skills including vendor management experience.
• Excellent internal and/or external influencing skills to achieve the program objectives.
• Analytical, process-oriented with a keen interest to drive continuous improvements.
• Self-starter with ability to work with minimal supervision in a highly matrixed and multi-cultural environment, taking full ownership of deliverables.
• Acting as a role model for all people within the organization.
• Strong can-do attitude and results-focused, with capability to think strategically.