Global Head Regulatory Affairs Solutions

Job Description Summary

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz
The Stakeholder Success Lead – Global Head Regulatory Affairs Solutions is focused on ensuring that Regulatory Affairs stakeholders successfully achieve their goals using the technology systems provided. This role involves closely working with Regulatory Affairs stakeholders to understand their evolving needs, challenges, opportunities, and priorities, and ensuring that their automation and information needs are met by collaborating with other members of their functional unit and/or other functional units. Stakeholder Success Leads play a crucial role in representing the face of Technology to the stakeholder community they serve.

Job Description

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz

The Stakeholder Success Lead – Global Head Regulatory Affairs Solutions is focused on ensuring that Regulatory Affairs stakeholders successfully achieve their goals using the technology systems provided. This role involves closely working with Regulatory Affairs stakeholders to understand their evolving needs, challenges, opportunities, and priorities, and ensuring that their automation and information needs are met by collaborating with other members of their functional unit and/or other functional units. Stakeholder Success Leads play a crucial role in representing the face of Technology to the stakeholder community they serve.

Key Responsibilities

• Stakeholder Engagement
  • Facilitate effective dialogues to identify business issues, challenges, and opportunities that can be addressed through technology.
  • Align Regulatory Affairs technology strategy with business directives and needs.
  • Manage Technology priorities for the Regulatory Affairs business area.
  • Develop and maintain relationships with key Regulatory Affairs leaders to ensure alignment of Technology services with Regulatory Affairs objectives.
  • Conduct regular meetings with Regulatory Affairs stakeholders to gather requirements and feedback.
• Project Management
  • Ensure the capture of functional requirements and design specifications for Regulatory Affairs technology solutions.
  • Coordinate technology delivery of the Regulatory Affairs’ IT portfolio and priorities, ensuring projects are on schedule and outcomes are of high quality.
  • Collaborate with Technology teams to develop and implement solutions that address Regulatory Affairs stakeholder needs.
  • Monitor and report on the progress of Regulatory Affairs Technology projects and initiatives.
  • Implement risk management strategies to ensure project success.
• Budget and Resource Optimization
  • Meet operational and project budgets.
  • Effectively lead and manage the Regulatory Affairs Stakeholder Success team.
  • Identify, manage, and improve vendor relationships.
  • Optimize resource allocation to ensure maximum efficiency and cost-effectiveness.
  • Develop and manage financial forecasts and budgets for technology projects.
• Innovation and Improvement
  • Identify opportunities for technological innovation within Regulatory Affairs.
  • Continually update personal knowledge of industry trends and developments to enhance solutions provided to Regulatory Affairs.
  • Maintain a detailed understanding of how Regulatory Affairs processes are operationalized within technology tools.
  • Encourage and support the adoption of new technologies and processes.
  • Lead pilot programs for new technology solutions and assess their effectiveness.
• Communication and Coordination
  • Drive the adoption of the Technology Organization’s standards and solutions.
  • Ensure smooth execution and maintain clear lines of communication between cross-functional Technology teams and Regulatory Affairs.
  • Coordinate with other functional units to ensure alignment and integration of technology solutions.
  • Develop and maintain communication channels to provide regular updates and feedback to stakeholders.

Major Accountabilities

• Stakeholder Engagement
  • Ensure high levels of Regulatory Affairs stakeholder satisfaction through proactive engagement and effective solution delivery.
  • Maintain ongoing communication with stakeholders to ensure their needs are continuously met.
  • Ensure stakeholder feedback is effectively communicated to the Technology team for continuous improvement.
• Project Management
  • Oversee the delivery of Regulatory Affairs technology projects, ensuring they align with stakeholder needs and organizational standards.
  • Ensure project milestones are met and deliverables are achieved within budget and time constraints.
  • Provide regular project status updates to stakeholders and management.
• Budget and Resource Optimization
  • Ensure all technology initiatives are completed within the allocated budget.
  • Maintain strong vendor relationships to secure favorable terms and high-quality services.
  • Lead the Regulatory Affairs Stakeholder Success team in achieving financial and operational goals.
• Innovation and Improvement
  • Champion innovation within the Technology department by leveraging industry insights and Regulatory Affairs stakeholder feedback.
  • Ensure the Regulatory Affairs is at the forefront of technological advancements.
  • Drive continuous improvement initiatives to enhance service delivery and operational efficiency.
• Communication and Coordination
  • Maintain effective communication channels between Technology teams and Regulatory Affairs to ensure alignment and smooth service delivery.
  • Ensure that all stakeholders are informed and engaged throughout the project lifecycle.
  • Facilitate effective collaboration and information sharing among team members.

Key Performance Indicators

• Stakeholder Satisfaction: Measured through surveys and feedback mechanisms.
• Project Management: Timeliness, budget adherence, and quality of Technology projects delivered.
• Business Alignment: Degree to which Technology solutions meet the strategic needs of the business.
• Innovation & Improvement: Tangible benefits realized from new technologies and processes implemented.

Minimum requirements:

Education

• Bachelor's degree in a relevant field (e.g., Computer Science, Business Administration).
• Master’s degree or advanced certification in Business Management, Technology Management, or related disciplines is preferred.

Work Experience

• 10-15 years’ industry experience in IT, healthcare, or pharma; expert understanding of technology and methodologies as applied in the respective area.
• Proven track record in project management and stakeholder satisfaction (ideally related to Regulatory Affairs business area).
• Tenure in a management role overseeing complex projects.
• Proven track record of developing and implementing Regulatory Affairs technology strategies.
• Demonstrated ability to lead and mentor a dispersed technology team.
• Experience in regulatory and compliance environments, understanding the implications for technology solutions and data management in global markets.
• History of successful stakeholder engagement and relationship management

Skills:

• 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.
• A proven track record of implementing digital solutions to enhance regulatory business 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.
• 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.

Languages

• Fluent English required (oral and written)

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art 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 and entrepreneurial spirit 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 encouraged

The future is ours to shape

Commitment to Diversity & Inclusion:

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

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Sandoz Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Sandoz and our career opportunities, join the Sandoz Network here:

#Sandoz

Skills Desired

Business Acumen, Business Requirement Technical Analysis, Customer Requirements, Financial Modeling Information Technology Consulting, Stakeholder Management, Strategic Leadership, Strategic Planning, Talent Development, Waterfall Project Management#J-18808-Ljbffr

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