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 objectiveRepresent 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 engagementBe 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) teamWork 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 useParticipate in internal efforts to create strategies that grow CSL business and regulatory science and policy goals across North America regionGather 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 experienceRegulatory 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 Vision401KPaid time Off

#LI-Hybrid

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

We want CSL to reflect the world around us

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.

Do work that matters at CSL Behring!