Director, Vaccines Lead, Global Regulatory Science, Policy, and Intelligence
This role’s primary responsibility is to advance vaccine regulatory science field, to monitor, anticipate and provide strategic analyses of global vaccine regulatory environment, and to actively participate in shaping of regulatory science vaccine field in collaboration and alignment with the Head of Global Regulatory Science & Policy and the global regulatory function internally (e.g.: forming CLSB positions) and externally (e.g.: ensuring CLS visibility and influence). The incumbent will keep the organization abreast of changes, trends, and developments of vaccines in the global regulatory environment, inform decision making and provide CSLB with a competitive advantage.
Main Responsibilities and Accountabilities
Advance Regulatory Science:
Contribute to the advancement of vaccine global regulatory science and shaping the global regulatory environment by identifying and coordinating non-product specific opportunities to interact and/or collaborate with global health authorities
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
Serve as the regulatory team’s subject-matter-expert in certain forums where CSLB vaccines policy strategy development and execution efforts are coordinated by Public and Government Affairs (PAGA) team and work with PAGA team and the GRA team to identify and align on vaccine regulatory policy goals and effective vaccine regulatory policy concepts for both internal and external use
Participate in internal efforts to create strategies that advance CSLB business and regulatory science & policy objectives across vaccine therapeutic area
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 for vaccines through an understanding of regulatory guidelines, regulations, and laws that may have an impact on CSLB’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, their potential impacts on CSLB’s products, commenting them to recommend the development of CSLB’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 CSLB to understand and prioritize regulatory risks and opportunities and formulate and shape aligned vaccine policies and positions on global 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, CSLB’s PAGA function, other Intelligence groups (e.g. Competitive Intelligence) and other functions as appropriate to stay abreast of changes in the global vaccine regulatory environment. The objective is to provide context and broader perspective but also to 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).
Position Qualifications and Experience Requirements
Minimum of Bachelor Degree in Science OR Medical Science or Pharmacy OR related medical science degree.
Masters, PHD, JD OR PharmD preferred
Bachelors OR post-graduate degree e.g. in Drug Regulatory Affairs advantageous
Bachelor's degree with minimum of 6 years of life science experience or drug regulatory affairs experience.
Regulatory experience or a solid combination of regulatory and/or related experience in both development and post-marketing phases
Knowledge and understanding of US and EU regulatory environment
PHD with minimum of 4 years of life science or drug regulatory affairs experience.
Previous experience in delivering regulatory policy and intelligence is an advantage
Experience working at or with FDA or EMA is desirable
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)
CSL Behring LLC will provide equal employment opportunity for all persons without discrimination on the basis of membership in a legally protected class, including race, color, religion, national origin, gender, age, veteran status, or handicap/disability.
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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, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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