Senior Manager, Regulatory Science, Policy, and Intelligence

CSL Behring: Global Biotechnology Leader

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 approximately 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.

Position: Senior Manager, Analyst, Regulatory Science, Policy, and Intelligence

Location: Washington DC (Hybrid position)

Reporting To: 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. Additionally, you will maintain operational aspects of the role, including the enhancement and maintenance of GRASP SharePoint and GRASP-related processes.

Key Responsibilities:

Help develop regulatory science, policy, and intelligence programs and help shape the regulatory environment for assigned platforms, departments, or topics.

Identify opportunities for non-product-specific collaboration with global regulatory authorities.

Collaborate with Global Regulatory Affairs, therapeutic areas, regional leads, and teams to support planning of 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.

Facilitate the process for assessing draft global regulations and regulatory guidelines, evaluate potential impacts on CSL products, recommend the development of CSL-specific positions, 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) to stay informed about changes in the North America regulatory environment. Identify global topics for surveillance and advocacy.

Experience & Qualifications:

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 who work at least 30 hours per week are eligible for benefits effective day 1. CSL offers resources and benefits, from health care to financial protection, to help you focus on work that matters. Our benefits are designed to support employees at every stage of life:

Starting a family

Emergency backup care or summer camp

Mental health resources

Financial planning

Charity support with matching contributions

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 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:

Plasma fractionation

Recombinant protein technology

Cell and gene therapy

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 lifesaving therapies to people in more than 100 countries.

Inclusion and Belonging at CSL:

At CSL, Inclusion and Belonging is at the core of our mission. It fuels our innovation day in and day out. By celebrating differences and creating a culture of curiosity and empathy, we better understand and connect with patients and donors, foster strong stakeholder relationships, and sustain a diverse workforce. Learn more: Inclusion and Belonging | CSL

Do work that matters at CSL Behring!

Apply here