Reg. Regulatory Lead Hematology – Europe LCM

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Summary:

As a regulatory leader you will be expected to leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient-centric focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes.  You will partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure ‘One GRA Voice’, appropriate inputs into risk assessment and decision making.  You will also ensure bi-directional communication with stationed region commercial operations and GRA.
With support, you will be engaging with health authority (HA) in stationed country (FDA or EMA), maintaining productive relationship with HA contacts and driving positive regulatory outcomes.

Main Responsibilities:

• Accountable for assigned product relationship with a health authority (FDA or EMA), ensuring alignment with product GRL and as needed, support from Head, Regulatory TA if escalation is required. 
• May negotiate on behalf of CSL with health authority to achieve desired regulatory outcome.
• Regional knowledge regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders (e.g. GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.
• Under the product GRL, supports regional regulatory activities as assigned, inclusive of potential to contribute to core document preparation (e.g. core briefing book, pediatric plans, etc.), product filing preparation activities (investigational, new and marketed) and health authority engagements. 
• Responsible for Module 1 documentation required for submission and supports response to health authority comments activities with guidance from GRL.
• Actively contribute to the GRAST activities, strategy development, document reviews and competitive regulatory intelligence. 
• Ensures on-time execution of regulatory activities at the regional level, achieving positive regulatory outcomes. 
• Partners with GRL to develop internal communications and distributes GRAS communications to regional commercial stakeholders.
• Actively connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC.
• Proactively fosters and promotes effective relationships across Global Regulatory Strategy.
• Updates and maintains applicable regulatory systems (e.g. Veeva) to ensure tracking and compliance deliverables.
• Applies the CSL Leadership Capabilities – Build Bridges, Think Beyond, Unleash Outcomes, Ignite Agility, Inspire the Future and Cultivate Talent – to oneself. 

Qualifications and Experience Requirements:

• Bachelor’s degree (four-year university degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required.  An advanced degree in a related field (MS, PhD or MD, DVM) or MBA is preferred.
• Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with exposure to regulatory activities / submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred.
• Experience in working in teams with either a direct or matrix manager. 
• Knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in one key region (EU, US, Japan).
• Experience working in Regulatory Affairs with agency interaction responsibility with at least 1 health authority is preferred.
• Relevant experience working in a complex and matrix environment is preferred. 
• Ideal candidates will have clinical or device foundation.
• Strong ethics and integrity
• Communication skills, with capacity to articulate complex concepts in a manner individuals at various levels in the organization can comprehend.
• Fluency in English (verbal and written).

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!