Global Director, Business Partner Regulatory Affairs Solutions

Job Description Summary

The Global Director, Business Partner Regulatory Affairs Solutions reports to the Global Head, Regulatory Affairs Solutions. The role is technology partner for a business area/sub capability of the company across all geographies. Accountable to Global Business Units for end-to-end technology support 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 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.

Job Description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

The Global Director, Business Partner Regulatory Affairs Solutions reports to the Global Head, Regulatory Affairs Solutions. The role is technology partner for a business area/sub capability of the company across all geographies. Accountable to Global Business Units for end-to-end technology support 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 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.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• 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.

Experience

• 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.

Skills:

• Strong Veeva Vault RIM (Registrations, Submissions, etc.) / Lorenz docuBridge or similar application knowledge and experience considered a plus.
• A proven track record of implementing digital solutions to enhance regulatory processes and experience in leading innovative projects that leverage AI, machine learning, and / or other advanced technologies to improve operational efficiency
• 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.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!

#Sandoz

Skills Desired

Budget Management, Business Acumen, Performance Management, Risk Management, Service Delivery Management, Stakeholder Management, Strategic Planning, Talent Development, Waterfall Project Management