Director of Global Regulatory Affairs Operations
vor 2 Wochen
We are seeking a highly experienced and skilled Director of Global Regulatory Affairs Operations to join our team at CSL Vifor. As a key member of our Global Regulatory Affairs department, you will be responsible for leading the Central Services Group (CSG) team, which is pivotal in shaping our ability to deliver efficient and timely worldwide submissions.
The successful candidate will have a strong background in Global Regulatory Affairs, with experience in dossier preparation, regulatory affairs processes, and compliance matters. They will also have a proven track record of building high-performing, diverse, and global teams, with a strong ability to partner and influence across a matrix environment.
The ideal candidate will be a strategic thinker, with a deep understanding of the pharmaceutical industry and regulatory affairs. They will be able to link long-ranging visions and concepts to daily work, and have a high level of flexibility, pragmatism, and solution-oriented working style.
Key Responsibilities
- Lead the global CSG team, responsible for prioritizing, planning, preparing, and coordinating all submissions related to the CSL Vifor, Seqirus, and Behring product portfolio.
- Supervise the centralized execution of administrative activities for the whole GRA department, including legalization, translation, and document management.
- Oversee the performance of several vendors for all above-mentioned activities, including performance management, resources monitoring, and turnover mitigation.
- Collaborate with Senior Leaders in CMC, Regions, and Labeling to understand their requirements and objectives, and establish forums to discuss and enhance CSG processes.
Requirements
- Advanced degree in Life Science or Business with a postgraduate qualification, with a master's degree in health or health engineering.
- 15+ years' experience in the pharmaceutical industry and Global Regulatory Affairs, with experience in dossier preparation, regulatory affairs processes, and compliance matters.
- 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, and solution-oriented working style.
- Fluent in English.
About CSL Vifor
CSL Vifor 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, hematology, cardiovascular, and metabolic, respiratory, and transplant therapeutic areas.
Why Join Us?
We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.
-
Director of Global Regulatory Affairs Operations
vor 4 Wochen
Opfikon, Zürich, Schweiz CSL Vifor VollzeitJob Title: Director of Global Regulatory Affairs OperationsCSL Vifor is a global biotechnology company with a dynamic portfolio of lifesaving medicines. We are seeking a highly skilled Director of Global Regulatory Affairs Operations to join our team.The successful candidate will be responsible for leading the global Central Services Group (CSG) team, which...
-
Director of Global Regulatory Affairs Operations
vor 4 Wochen
Opfikon, Zürich, Schweiz CSL Vifor VollzeitJob Title: Director of Global Regulatory Affairs OperationsCSL Vifor is a global biotechnology company with a dynamic portfolio of lifesaving medicines. We are seeking a highly skilled Director of Global Regulatory Affairs Operations to join our team.The successful candidate will be responsible for leading the global Central Services Group (CSG) team, which...
-
Director of Global Regulatory Affairs Operations
Vor 7 Tagen
Opfikon, Zürich, Schweiz CSL Vifor VollzeitCSL Vifor is a global biotechnology company with a dynamic portfolio of lifesaving medicines. As the Director of Global Regulatory Affairs Operations, you will play a pivotal role in shaping the company's ability to deliver efficiently and timely our worldwide submissions.The Global Regulatory Affairs Operations team is responsible for prioritizing,...
-
Director of Global Regulatory Affairs Operations
vor 1 Woche
Opfikon, Zürich, Schweiz CSL Vifor VollzeitJob SummaryCSL Vifor is seeking a highly skilled and experienced professional to lead our Central Services Group (CSG). As the Director of Global Regulatory Affairs Operations, you will be responsible for building and managing a global team that prioritizes, plans, prepares, and coordinates all submissions related to our product portfolio.Key...
-
Director of Global Regulatory Affairs Operations
vor 1 Woche
Opfikon, Zürich, Schweiz CSL Vifor VollzeitCSL Vifor 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.Our company has been driven by our promise to save lives using the latest technologies since our start in 1916. Today, we...
-
Regional Regulatory Affairs Specialist
vor 2 Monaten
Opfikon, Zürich, Schweiz CSL VollzeitJob Purpose:We are seeking an experienced Regulatory Affairs professional to lead our Cardio-Renal Therapeutic Area in the Intercontinental Region. As a key member of our Global Regulatory Affairs team, you will develop regional strategies, contribute to global regulatory strategies, and submit regulatory applications to obtain Health Authority approval in...
-
Regional Regulatory Affairs Manager
vor 4 Wochen
Opfikon, Zürich, Schweiz CSL VollzeitJob Purpose:We are seeking an experienced and skilled Regulatory Affairs professional to lead the Cardio-Renal Therapeutic Area in the Intercontinental Region. As a key member of the Global Regulatory Affairs team, you will develop regional strategies, contribute to global regulatory strategies, and submit regulatory applications to obtain Health Authority...
-
Regional Regulatory Affairs Specialist
Vor 7 Tagen
Opfikon, Zürich, Schweiz CSL VollzeitJob Purpose:We are seeking a highly experienced Regulatory Affairs Specialist to lead the development of regional strategies and contribute to global regulatory strategies for the Cardio-Renal Therapeutic Area in the Intercontinental Region. You will be responsible for submitting regulatory applications for development products and change applications for...
-
Senior Regulatory Affairs Specialist
Vor 3 Tagen
Opfikon, Zürich, Schweiz CSL VollzeitJob Purpose:CSL is seeking a highly experienced and skilled Regulatory Affairs Specialist to lead the development of regional strategies in the Cardio-Renal Therapeutic Area. This individual will contribute to global regulatory strategies and submit regulatory applications for development products and change applications for registered products to obtain...
-
Head of Medical Affairs Europe
vor 2 Monaten
Opfikon, Zürich, Schweiz CSL Vifor VollzeitAbout the RoleWe are seeking a highly experienced and strategic medical leader to join our team as the Head of Medical Affairs, Europe. This critical role will oversee the medical affairs strategy across Europe, ensuring alignment with global objectives and fostering collaboration across various functions.Main ResponsibilitiesLeadership and Governance:...
-
Head of Medical Affairs Europe
vor 1 Monat
Opfikon, Zürich, Schweiz CSL Vifor VollzeitAbout the RoleWe are seeking an experienced and strategic medical leader to join our team as the Head of Medical Affairs, Europe. In this critical role, you will oversee the medical affairs strategy across Europe, ensuring alignment with global objectives and fostering collaboration across various functions.Main ResponsibilitiesLeadership and Governance:...
-
Head of Medical Affairs Europe
vor 1 Monat
Opfikon, Zürich, Schweiz CSL Vifor VollzeitAbout the RoleWe are seeking an experienced and strategic leader to join our team as the Head of Medical Affairs, Europe. In this critical role, you will oversee the medical affairs strategy across Europe, ensuring alignment with global objectives and fostering collaboration across various functions.Main ResponsibilitiesStrategic Leadership: Develop and...
-
Head of Medical Affairs Europe
vor 1 Monat
Opfikon, Zürich, Schweiz CSL Vifor VollzeitAbout the RoleWe are seeking an experienced and strategic leader to join our team as the Head of Medical Affairs, Europe. In this critical role, you will oversee the medical affairs strategy across Europe, ensuring alignment with global objectives and fostering collaboration across various functions.Main ResponsibilitiesStrategic Leadership: Develop and...
-
Director of Pharmacovigilance Operations
vor 18 Stunden
Opfikon, Zürich, Schweiz CSL VollzeitThe Role of a Leader in PharmacovigilanceAs Head of QPPV Office and PV Intelligence, you will be responsible for the direction and management of the QPPV office team and the PV Intelligence function. This includes ensuring accurate descriptions are in place of CSL’s Pharmacovigilance system, in compliance with applicable legislative requirements. You will...
-
Global Head of Medical Evidence Generation
vor 1 Monat
Opfikon, Zürich, Schweiz CSL Vifor VollzeitMain ResponsibilitiesThe Global Head of Medical Evidence Generation will play a pivotal role in shaping evidence generation across CSL Vifor. Reporting to the VP, Global Head of Medical Affairs, this individual will define the overarching RWE strategy across the portfolio, aligning with overall evidence generation activities and translating data to insights...
-
Global Head of Medical Evidence Generation
vor 4 Wochen
Opfikon, Zürich, Schweiz CSL Vifor VollzeitGlobal Head of Medical Evidence GenerationAbout the RoleWe are seeking a highly skilled and experienced professional to lead our Medical Evidence Generation team. As the Global Head of Medical Evidence Generation, you will be responsible for developing and implementing strategies to generate high-quality medical evidence to support our products and...
-
Global Head of Medical Evidence Generation
vor 3 Wochen
Opfikon, Zürich, Schweiz CSL Vifor VollzeitGlobal Head of Medical Evidence GenerationAbout the RoleCSL Vifor is seeking a highly skilled and experienced Global Head of Medical Evidence Generation to join our team in Zurich, Switzerland. As a key member of our Medical Affairs department, you will be responsible for leading the development and implementation of evidence generation strategies across the...
-
Global Head of Medical Evidence Generation
vor 3 Wochen
Opfikon, Zürich, Schweiz CSL Vifor VollzeitGlobal Head of Medical Evidence GenerationAbout the RoleWe are seeking a highly skilled and experienced professional to lead our Medical Evidence Generation team. As the Global Head of Medical Evidence Generation, you will be responsible for developing and implementing strategies to generate high-quality medical evidence to support our products and...
-
Global Head of Medical Evidence Generation and Strategy
vor 2 Monaten
Opfikon, Zürich, Schweiz CSL Vifor VollzeitAbout the RoleWe are seeking a highly skilled and experienced professional to lead our Medical Evidence Generation and Strategy team at CSL Vifor. As the Global Head of Medical Evidence Generation and Strategy, you will play a pivotal role in shaping our evidence generation activities across the organization.Key ResponsibilitiesDevelop and Implement Evidence...
-
Global Head of Medical Evidence Generation
vor 1 Monat
Opfikon, Zürich, Schweiz CSL Vifor VollzeitGlobal Head of Medical Evidence GenerationAbout the RoleWe are seeking a highly skilled and experienced Global Head of Medical Evidence Generation to join our team at CSL Vifor. As a key member of our Medical Affairs department, you will play a pivotal role in shaping our evidence generation strategy across the organization.Main ResponsibilitiesDevelop and...
