Director, Regulatory Science, Policy & Intelligence- North America Lead

Reporting to the Head of Global Regulatory Science, Policy, and Intelligence, your primary responsibility will be to promote the regulatory science field, provide strategic analyses of the North America regulatory environment, and to participate in the shaping of the regulatory science field according to the global regulatory function internally (e.g.: forming CLSB positions) and externally (e.g.: ensuring CSL visibility and influence). You will keep the organization informed about changes, trends, and developments of the regulatory environment, inform decision-making, and provide CSL Behring (CSLB) with a competitive advantage.

Note: This role can be remotely-based within the US Eastern Time Zone.

Responsibilities:

Advance Regulatory Science:

• Contribute to the advancement of North America regulatory science and shaping the global regulatory environment by identifying and coordinating non-product specific opportunities to work or collaborate with global health authorities
• Work within the Global Regulatory Affairs (GRA) team to develop strategies for external partner engagement for each necessary regulatory policy roadmap objective
• Represent CSLB in multi-stakeholder forums including: 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
• Be the regulatory team's subject-matter-expert in certain forums where CSLB North America policy strategy development efforts are coordinated by Public and Government Affairs (PAGA) team and work with PAGA team and the GRA team to identify and agree on regulatory policy goals and vaccine regulatory policy concepts for both internal and external use
• Participate in internal efforts to create strategies that promote CSLB business and regulatory science and policy goals across North America region
• Help prepare for meetings and interactions with health authorities to discuss regulatory science topics.

Gather, analyze, assess, and communicate relevant global regulatory information and trends 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 improve regulatory expertise. 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 agree on an action plan with the Head of Global Regulatory Science & Policy.

Work with Subject Matter Experts within CSLB to prioritize regulatory risks and opportunities and create and shape aligned policies and positions on North America regulatory topics.

Contribute to the development of a Regulatory Policy Roadmap and measurement of efficiencies through impact assessment measures and goals.

Collaborate with global regulatory functions, CSLB's PAGA function, other Intelligence groups (e.g. Competitive Intelligence) and other departments to stay up-to-date with changes in North America regulatory environment. The objective is to provide context and broader perspective but also to identify global topics for surveillance and advocacy.

Work with external parties/consultants to support the Regulatory Intelligence process (access to sources of data gathering, analysis and distribution).

Education/Experience:

• Bachelor's Degree required with preferred focus in the life sciences or Medical Science or Pharmacy; post-graduate qualification or degree in Regulatory Affairs is advantageous
• Minimum of 6 years of life science experience
• Regulatory experience or a solid combination of regulatory and related experience in both development and post-marketing phases
• Understanding of US regulatory environment
• Previous experience delivering regulatory policy and intelligence is an advantage
• Experience working at or with FDA or EMA is desirable

Travel requirements: up to 25%, including 1 week per month to King of Prussia, PA office

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Our Benefits

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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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