Director Global Regulatory Science, Policy, and

vor 5 Monaten

Bern, Schweiz CSL Behring Vollzeit

This role’s primary responsibility is to advance the regulatory science and policy field, to monitor, anticipate and provide strategic analyses of t; he European regulatory environment, and to actively participate in the shaping of the regulatory science and policy field in collaboration and alignment with the Head of Global Regulatory Science & Policy and the global regulatory function internally (e.g.: forming CLS positions) and externally (e.g., ensuring CLS visibility and influence). The incumbent will keep the organization abreast of changes, trends, and developments of the regulatory environment, inform decision making and provide CSL with a competitive advantage.

**Role responsibilities**
- Contribute to the advancement of Europe regulatory science and policy and shaping the global regulatory environment by identifying and coordinating non-product specific opportunities to interact and/or collaborate with health authorities in Europe.
- Work within the GRA team to create and implement strategic plan for external stakeholder engagement for each key regulatory policy roadmap objective.
- Represent CSLB in multi-stakeholder forums including but not limited to: trade associations committees, think tanks, patient advocacy organizations, professional associations, international congresses, and other high-value opportunities for scientific and regulatory exchange, and ensure such opportunities are maximized by productive and concrete engagement
- Participate in internal efforts to create strategies that advance CSL business and regulatory science & policy objectives across European region.
- Assist in preparing for meetings and interactions with health authorities to discuss regulatory science topics.
- Gather, analyze, assess, and timely communicate relevant global regulatory information and trends through an understanding of regulatory guidelines, regulations, and laws that may have an impact on CSL’s products and regulatory business processes.
- Contribute to and inform a Global Regulatory Intelligence (RI) strategy aiming at delivering regular RI updates by providing education, knowledge sharing, newsletters, reports, and other modes of communication to advance regulatory expertise and decision-making. Effectively communicate (verbally, written) on assigned regulatory intelligence topics to a diverse audience.
- Facilitate the process for assessing draft global regulations and regulatory guidelines, and their potential impacts on CSL’s products, commenting on them to recommend the development of CSL’s specific position, and propose and align on an action plan with the Head of Global Regulatory Science & Policy.
- Work with Subject Matter Experts within CSL to understand and prioritize regulatory risks and opportunities and formulate and shape aligned policies and positions on European regulatory topics.
- Contribute to the development and maintenance of a Regulatory Policy Roadmap and measurement of efficiencies through impact assessment measures and KPIs.
- Collaborate with global regulatory functions, CSL’s PAGA function, other Intelligence groups (e.g. Competitive Intelligence) and other functions as appropriate to stay abreast of changes in European regulatory environment. The objective is to provide context and a broader perspective and identify and prioritize global topics for surveillance and advocacy.
- Work with external parties/consultants as appropriate to support the Regulatory Intelligence process (access to sources of information, data gathering, analysis, and dissemination).

**Background education, past experiences, and skills**
- A degree in life sciences (at least BSc) or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous
- Minimum of 6 years of life science experience
- Regulatory experience or a solid combination of regulatory and/or related experience in both development and post-marketing phases
- Knowledge and understanding of European regulatory environment.
- Previous experience in delivering regulatory policy and intelligence is an advantage.
- Superior communication and presentation skills in English, both verbal and written
- "Big picture thinker" with strong business perspective
- Ability to influence and develop a network.
- Ability to work in a team, high customer focus, and innovative thinking.
- Embraces change and should possess the ability to effectively work in an international, multicultural and matrix environment.
- Business travels will be required (up to 20% of the time)

**Our Benefits**:
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.

**About CSL Behring**:
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, hemato

  • Director, Global Labeling Data Strategy Lead

    vor 5 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    As a member of the GL leadership team, the director, GL data strategy and team assess and communicate the impact of key clinical endpoints on a future label. You will influence by articulating how agency advice and precedence and the competitive landscape support or require modifications to the design to deliver desired label outcomes. The position then maps...

  • Global Feasibility Director

    Vor 6 Tagen

    Bern, Bern, Schweiz CSL Vollzeit

    As the Associate Director, Global Feasibility at CSL, you will be responsible for leading the development of feasibility strategies across clinical programs and delivering their end-to-end processes.Main Responsibilities and AccountabilitiesAccountable for the development of the feasibility strategy across clinical programs and delivering its end-to-end...

  • Director of Global Clinical Operations

    vor 1 Monat

    Bern, Bern, Schweiz CSL Vollzeit

    Exciting Opportunity at CSL:Are you a dynamic candidate with outstanding analytical skills and strong communication abilities? Join CSL as the Associate Director of Global Feasibility and be part of a team dedicated to feasibility and study start-up delivery. This role involves developing feasibility strategies, collaborating with internal and external...

  • Global Regulatory Affairs Cmc Scientist in The

    vor 5 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    Do you want to work in a global team and support worldwide registrations for Albumins? The Global Regulatory Affairs CMC Scientist is part of a global team of eight responsible for over 150 Albumins licenses in almost 100 countries worldwide. Albumin is manufactured at four CSL Behring sites and contributes significantly to the companies’ revenue. The...

  • Associate Director, Global Feasibility

    vor 5 Monaten

    Bern, Schweiz CSL Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...

  • Associate Director, Global Feasibility

    vor 3 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    The **Associate Director, Global Feasibility,** is the strategic interface with Clinical Development and Clinical Portfolio Execution to provide quality-by-design/strategic insight on protocol and country early feasibility and build allocation strategy scenarios in line with budget. The role is also the primary interface with the Global Medical Affairs and...

  • Strategic Associate Director, Global Feasibility Lead

    vor 2 Monaten

    Bern, Bern, Schweiz CSL Vollzeit

    Job SummaryCareer Opportunities at CSLCareer Opportunities at CSLJob DescriptionThe Associate Director, Global Feasibility role is a key position within CSL, responsible for providing strategic insight and guidance on protocol and country early feasibility and build allocation strategy scenarios in line with budget. This role will collaborate closely with...

  • Associate Director, Global Feasibility Lead

    vor 1 Monat

    Bern, Bern, Schweiz CSL Vollzeit

    Job SummaryCareer Opportunities at CSLWe are seeking a highly skilled and experienced Associate Director, Global Feasibility to join our team at CSL. This role will be responsible for developing and implementing the feasibility strategy across clinical programs, ensuring timely and cost-effective delivery of study start-up activities.Main...

  • Senior Director, Quality Control Operations

    vor 4 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Job Title: Senior Director, Quality Control OperationsCSL Behring is seeking a highly experienced Senior Director, Quality Control Operations to lead our global quality control organization. As a key member of our leadership team, you will be responsible for ensuring the quality and integrity of our products, while driving process improvements and ensuring...

  • Regulatory Strategy Manager

    vor 1 Monat

    Bern, Bern, Schweiz CSL Vollzeit

    Job Purpose:We are seeking an experienced and skilled Regulatory Affairs professional to lead the development of regional strategies and contribute to global regulatory strategies for the Cardio-Renal Therapeutic Area in the Intercontinental Region. As a key member of the Global Regulatory Affairs team, you will be responsible for submitting regulatory...

  • Senior Director, Quality Control Operations

    vor 4 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Job Title: Senior Director, Quality Control OperationsThis role is responsible for leading the global quality control organization, ensuring compliance with regulatory requirements and corporate standards. The ideal candidate will have a strong background in quality management, with experience in laboratory and stability functions.Key Responsibilities:Lead...

  • Director of Payer Partnerships

    vor 2 Monaten

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Payer Partnerships Director Job DescriptionThe Payer Partnerships Director will be responsible for developing and advancing payer partnerships and policy-shaping strategies for assigned product categories, with a focus on high-impact areas. This role ensures we are continuously monitoring and shaping critical changes within the dynamic payer environment and...

  • Regional Regulatory Affairs Specialist

    vor 3 Wochen

    Bern, Bern, Schweiz CSL Vollzeit

    Job Purpose:We are seeking a highly experienced Regulatory Affairs Specialist 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 for development products and change...

  • Regional Regulatory Affairs Specialist

    vor 3 Wochen

    Bern, Bern, Schweiz CSL Vollzeit

    Job Purpose:We are seeking a highly experienced Regulatory Affairs Specialist to lead our Cardio-Renal Therapeutic Area in the Intercontinental Region. As a key member of our Global Regulatory Strategy Team, you will develop regional strategies, contribute to global regulatory strategies, and submit regulatory applications for development products and change...

  • Payer Partnerships Director

    vor 3 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Payer Partnerships DirectorThe Payer Partnerships Director will be responsible for developing and advancing payer partnerships and policy-shaping strategies for assigned product categories, with a focus on high-impact areas. This role ensures we are continuously monitoring and shaping critical changes within the dynamic payer environment and taking...

  • Senior Director, Quality Control Operations

    vor 3 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Job SummaryWe are seeking a highly experienced Senior Director, Quality Control Operations to lead our global quality control organization. As a key member of our leadership team, you will be responsible for ensuring the quality and integrity of our products, while driving process improvements and compliance with regulatory requirements.Key...

  • Global Category Lead Director

    vor 3 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Job SummaryCSL Behring is seeking a highly experienced and skilled Global Category Management Director to lead our global category management teams. The successful candidate will be responsible for developing and executing category management strategies across the entire CSL group, ensuring best possible value for CSL while managing risk and maintaining...

  • Senior IP and Regulatory Exclusivity Lawyer

    Vor 6 Tagen

    Bern, Bern, Schweiz CSL Vollzeit

    About the RoleThe Senior IP and Regulatory Exclusivity Lawyer will lead complex regulatory exclusivity and other related activities, including loss of exclusivity strategies, taking into account the IP landscape and broader political and commercial environment.This position will report to the head of IP and be a member of the enterprise global IP leadership...

  • Director of Payer Partnerships

    vor 1 Monat

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Payer Partnerships and Policy DevelopmentCSL Behring is seeking a highly skilled Director of Payer Partnerships and Policy to join our team. As a key member of our organization, you will be responsible for developing and advancing payer partnerships and policy-shaping strategies for assigned product categories.Key Responsibilities:Payer Partnerships...

  • Senior Director, Quality Control Operations

    vor 3 Wochen

    Bern, Bern, Schweiz CSL Vollzeit

    Job SummaryAs a Senior Director, Quality Control Operations, you will be responsible for leading the global quality control organization and ensuring compliance with regulatory requirements. You will manage a team of quality control professionals and oversee the development and implementation of quality control processes and procedures. You will also be...