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 Senior Manager, Analyst, Regulatory Science, Policy, and Intelligence? The job is in our Washington DC office. This is a hybrid position. You will report to the Head of Global Regulatory Science, Policy, and Intelligence.

You will provide strategic and operational support to the Lead for North America, Regulatory Science, Policy, and Intelligence in advancement of regulatory science, policy, and intelligence. This will be achieved in close collaboration with the Head of Global Regulatory Science & Policy, Europe and APAC regional function leads, and internal global regulatory teams. You will monitor regulatory trends, changes, and developments to inform strategic decision-making and maintain a competitive edge for CSL. Also, you will maintain operational aspects of the role, including the enhancement and maintenance of GRASP SharePoint and GRASP related processes.

Help develop regulatory science, policy, and intelligence science programs and help shape the regulatory environment for assigned platforms, departments, or topics. Help identify opportunities for non-product-specific collaboration with global regulatory authorities. Collaborate with Global Regulatory Affairs, therapeutic areas, regional leads, and teams to support the planning external engagement strategies.

Monitor, and share important regulatory trends and developments that could affect CSL's platforms or focus areas. Contribute to regular updates, reports, and other communications that support regulatory decision-making and knowledge sharing across the organization.

Contribute to the development and tracking of the Regulatory Policy Roadmap and support measuring progress through Indicators. Work with regional leads, internal regulatory teams, and other responsibilities such as Public and Government Affairs (PAGA) to align efforts and share insights. s.

Facilitate the process for assessing draft global regulations and regulatory guidelines, their potential impacts on CSLs products, commenting them to recommend the development of CSLs specific position, and propose and agree on an action plan with the Head of Global Regulatory Science & Policy

Collaborate with global regulatory functions, CSL PAGA function, other Intelligence groups (e.g., Competitive Intelligence) and other tasks to stay informed about 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.

Experience

Bachelor's degree in life sciences, PharmD, JD, or PhD preferred

3+ years of experience in the life sciences industry, with exposure to regulatory affairs or a related function.

Understanding of regulatory requirements across product development and post-marketing phases; prior firsthand regulatory experience

Familiarity with US regulatory systems; additional global exposure

Experience contributing to regulatory intelligence or policy work is beneficial.

Previous interaction with regulatory agencies such as FDA is a plus.

BENEFITS

Medical, Dental Vision

401K

Paid 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!