Global Specialist, Solutions Delivery Regulatory Affairs Solutions, GDPP, Technolog

Global Specialist, Solutions Delivery Regulatory Affairs Solutions, GDPP, Technology

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!

Job Summary

The Global Specialist, Solution Delivery Regulatory Affairs Solutions reports to the Global Head of Technology, Regulatory Solutions. This role is responsible for managing service delivery for a Regulatory Affairs business area across all geographies. The position is accountable for end-to-end project delivery and/or operations within the Regulatory Affairs solutions portfolio. The specialist partners with business stakeholders and technology teams for demand analysis, solution proposal and evaluation, and project delivery.

Your Key Responsibilities

Your responsibilities include, but are not limited to:

• Define and execute technology delivery strategy for business systems, platforms, and processes for Regulatory Affairs business domain/function(s)
• Partner with 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 Regulatory Affairs business domain
• Ensure services, solutions, products are fit for purpose and achieve the desired business value and impact
• Track, report, and deliver against agreed success factors and KPIs for various stakeholders for Regulatory Affairs business domain
• Follow industry trends and emerging practices to drive agility, speed, efficiency, and effectiveness. Ensure the overall user experience is considered when designing deploying new solutions and services
• Take accountability to ensure adherence to Security and Compliance policies and procedures

Minimum Requirements

What you’ll bring to the role:

• Minimum 3 to 5 years of industry experience in IT, healthcare, or pharma; expert understanding of technology and methodologies as applied in the respective area
• Veeva Vault RIM (Registrations, Submissions, etc.) or similar solutions knowledge and experience considered a plus
• Good knowledge of IT processes and experience in validated environments (GxP)
• Experience and understanding of Agile product development
• Good experience in technical planning, system integration, verification and validation, evaluating alternatives including cost, risk, supportability and analyses for systems total cost of ownership and return on investment of various IT platform/infrastructure alternatives
• Sound knowledge of Regulatory Affairs business processes and complexities (or other highly regulated domains)
• Ability to communicate effectively with stakeholders, manage issues, resolve conflicts, and mitigate risks.
• High display of Sandoz Values & Behaviors

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!

Commitment to Diversity & Inclusion (hard coded in Workday):

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)

#Sandoz