Global Regulatory Affairs Digitalization Lead

vor 4 Wochen

Bern, Schweiz CSL Behring Vollzeit

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, haematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

Global Regulatory Affairs is a Core Function of CSL R&D and the bridge between our company and all Health Authorities across the globe. To put it simply, Global Regulatory Affairs is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.

Global Regulatory Affairs at CSL has a global footprint with more than 330 employees from 30 different nationalities.

Digital transformation is one key pillar of our CSL and Global Regulatory Affairs strategy. We want to foster a mindset of continuous improvement using digital technologies to fundamentally change the way we operate and deliver value to our stakeholders.

Digital transformation is a significant undertaking for any organization, therefore our Global Regulatory Affairs Operations and Business Operations Excellence Leadership team is looking now for its Digitalization Lead

We are now opening this position for an experienced and dedicated person to join our team of passionate specialists in the field of Regulatory Affairs.

As Global Regulatory Affairs Digitalization Lead you will drive the development and execution of the Regulatory Affairs Digital Transformation strategy by considering the strategy of major regulators, benchmarking best practices, internal expectations, overall GRA 2030 strategy and also ensures its execution.

You will positioned yourself as a key partner for GRA community and beyond for all matters related to Digitalization. You will help to set up a performing and evolving GRA organization fit for the future being able to leverage digital technologies. Your role will be to enables GRA digital transformation and value creation through new tools and technologies and to communicate on the importance of digitalisation throughout the entire Global Regulatory Affairs department.

You will be the key contact point for all Digital technology and observe the latest trend in the outside world (Health Authorities, trade associations but not only).

**Role and Responsibilities**:

- Create and support an environment of digital innovation and best practice (like the annual CSL GRA Digitalization summit), ensuring the use of technologies for the benefit of stakeholders and members
- Create and embed a prioritisation approach to develop a roadmap for Digital transformation with the relevant processes, tools and metrics to support business objectives and new opportunities
- Establish and drive execution of a set of projects and programs ensuring access to cost-effective, state-of-the-art technology platforms/solutions
- Lead some digitalization projects when required or relevant
- Propose adoption of new Technology to improve ways of working
- Act as a strategic advisor and will be accountable in identifying and delivering relevant data & digital solutions that add tangible business value
- Strong interactions with:

- Regulatory Affairs and Policy Intelligence team to monitor upcoming trends in the regulatory digital environment in relevant markets to ensure that the client is adequately adapting so it remains competitive over time
- R&D enabling Technology and I&T Digital Platform leaders to develop and implement strategy for digital platform pipeline development
- Senior stakeholders at all levels in the organization and is comfortable both at discussing strategy and roadmap as well as getting hands-on when required and has the ability to get “things done” on behalf of his/her stakeholders through a formal and an informal network in a globally matrixed Data & Digital organization

**Educational Background and past experiences**
- Advanced degree in a technical related discipline or Business (Master, PhD, MBA)
- Knowledge of the contemporary digital landscape of organisations and experience of bringing leading technology and process optimisation practices to an organisation to drive sustainable improvements in business performance
- Previous experience with track records advanced technologies i. e. Data Science, AI, Process Automation is required
- Strong aptitude to read and translate the latest developments in technological evolutions (like big data, artificial intelligence, machine learning, process automation) as well as connecting them to the actual processes, cultural models and infrastructures of the Global Regulatory Affairs
- Be flexible, pragmatic, solution-oriented, independent and proactive working style.
- Be able to link long ranging visions/concepts to daily work.
- Developed skills to lead, coordinate and synchronize multiple projects, overcome obstacles and be flexible in changing dail

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