CSL is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people.

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.

GRA has a global footprint with more than 400 employees from 30 different nationalities growing, not just in numbers, but in diversity of expertise and experience.

At GRA, we are committed to consistently seeking efficiency, leveraging its resources, fostering innovation, and embracing new ways of working.

This is why we decided to create a “Central Service Group” (CSG) to enhance productivity through simplified and harmonized processes, improving planning, forecasting, submission management, and cross-functional collaboration. CSG will allows other functions (Regions, CMC, and Labeling) to enhance expert leverage, focus on core responsibilities, and contribute more strategically. Additionally, CSG will provide professional development opportunities by opening new career paths, increasing job attractiveness with a wide scope, and offering entry into the regulatory field.

In this role, you will be reporting to the Head of Global Regulatory Affairs Operations Excellence

Role and Responsibilities

Build, develop and manage the global CSG team by Identifying and retaining talent, conducting interviews, and fostering a positive, productive work environment. The role is pivotal in shaping GRA ability to deliver efficiently and timely our worldwide submissions by assembling a CSG team capable of delivering High quality results. Continuously seek efficiency gains by exploring and leveraging new ways of working and operating

- Lead the global CSG regulatory group (around 20 CSL employees and 10+ external FTEs), responsible for prioritizing, planning, preparing and coordinating all submissions related to the CSL Vifor, Seqirus and Behring for development (including first wave countries) and marketed product portfolio (around 3000-3500 submissions per year).

- Supervise the centralized execution of administrative activities for the whole GRA department including legalization, Translation CPP, GMP certificate, registration samples and any document requiring wet ink signature in collaboration with the concerned line function in the countries of origin/reference.
- Oversee the performance of several vendors for all above mentioned activities: performance management, resources monitoring, turnover mitigation plan, governance committees' participation, operating model adjustment and evolution.

-You will collaborate with:

• Senior Leaders in CMC, Regions and Labeling to thoroughly understand their requirements and objectives. This collaboration aims to foster a comprehensive understanding of strategic goals and operational necessities. Establish forums to discuss and enhance CSG processes.
• Operations Excellence (OpX) peers in Publishing and Regulatory Project Management to streamline processes and enhance overall efficiencies submission coordination processes. This collaboration focuses on meeting expectations set forth by the Global Regulatory Affairs Strategy Team (GRAST)

Background education, experience, and requirements

• Advanced degree in Life Science or Business with a post graduate qualification, with a master’s degree in health/Health Engineer.
• 15+ years' experience in the pharmaceutical industry and Global Regulatory Affairs (CMC, Labeling, Regions, Operations)
• Experience in dossier preparation for core countries but also international markets, regulatory Affairs processes, and compliance matters
• Experience with the Veeva RIM Suite is appreciated.
• 10+ years' leadership experience with global regulatory teams ideally in building high-performing, diverse and global teams located on various time zones.
• High level of flexibility, pragmatism,
• You are solution-oriented, independent, and proactive working style.
• You can link long ranging visions/concepts to daily work.
• You demonstrated success in partnering and influencing across a matrix environment is required.
• You are fluent in English

Was wir bieten

Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, was wir bei CSL bieten .

Über CSL Behring

CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring .

CSL soll so vielfältig sein wie die Welt, in der wir leben

Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über Vielfalt, Fairness & Inklusion bei CSL.

Machen Sie mit Ihrer Arbeit bei CSL einen Unterschied!