Director, Regulatory Science, Policy, and Intelligence

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

Could you be our next Director, Regulatory Science, Policy, and Intelligence for the North America Regions? The job is located in our Washington DC office. It is a hybrid role. You will report to the Head of Global Regulatory Science and Policy.

You will promote the regulatory science field, to monitor strategic analyses of North America regulatory environment, and to participate in shaping of regulatory science and policy field in collaboration and understanding of 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). You will keep us informed of changes, trends, and developments of regulatory environment, inform decision-making and provide CSL with a competitive advantage.

Responsibilities:

• Identify non-product specific opportunities to work and collaborate with US FDA
• Work within the GRA team to create plans for external partner engagement for each important regulatory policy roadmap objective
• Represent CSL 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 a regulatory team's subject-matter-expert in forums where CSL North America policy strategy development efforts are coordinated by Public and Government Affairs (PAGA) team
• 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 grow CSL business and regulatory science and policy goals across North America region
• Gather and analyze relevant global regulatory information and trends through an understanding of regulatory regulations that may have an impact on CSL products and regulatory business processes.

Qualifications:

• Bachelor's degree in life sciences, PharmD, JD, or PhD
• 6+ years regulatory experience in the pharmaceutical industry, Biologics Regulatory experience
• Regulatory experience or a solid combination of regulatory or related experience in both development and post-marketing phases
• Knowledge of US regulatory environment
• Experience working at or with FDA is desirable

Benefits:

• Medical, Dental Vision
• 401K
• Paid time Off