Director, Sr. Global Regulatory Lead - Cardiorenal

CSL Behring Vifor seeks a Director, Sr. Global Regulatory Lead for Cardiorenal to shape global regulatory strategies and lead the Global Regulatory Affairs Strategy Team in EMEA.

This position serves as a pivotal member of the Global Regulatory Strategy Therapeutic Area, aligning with CSL’s broader vision. The primary purpose is to craft and execute a comprehensive, patient-focused regulatory strategy for assigned products on a global scale.

Responsibilities

• Serve as the sole Global Regulatory Affairs Strategy Team (GRAST) representative for Product Strategy Teams and lead the GRAST.
• Direct interactions with major health authorities, such as the FDA and EMA, to cultivate productive relationships that ensure favorable regulatory outcomes worldwide.
• Coordinate with GRAST members to ensure the delivery of regulatory outputs, fostering a culture of accountability and collaboration while acting as the final approver for key deliverables.
• Oversee Regional Regulatory Leads, providing mentorship and supporting their professional development and career progression.
• Manage strategic partnerships with key health authorities and collaborate with regional leads to handle interactions outside the home country.
• Act as the primary reviewer and approver for critical regulatory documents and participate in high-level regulatory due diligence discussions.
• Lead the preparation of essential regulatory submissions and mentor team members to enhance their capabilities.
• Leverage regulatory intelligence, analytics, and cross-functional expertise to formulate robust global regulatory strategies.
• Promote consistency, knowledge sharing, and collaboration across all Global Regulatory Strategy teams.
• Coach team members to develop innovative solutions and ensure the timely execution of regulatory plans.
• Apply CSL leadership principles to support talent development, succession planning, and team empowerment.

Requirements

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or a related life science field.
• At least 10 years of experience in the biotech or pharmaceutical industry.
• Minimum of 8 years of experience in regulatory affairs.
• 5 years of experience specifically with developmental products.
• Proven experience in leading teams.
• Solid understanding of product development and regulatory requirements across major regions, including the EU, US, and Japan.
• Direct experience interacting with at least one health authority.

Nice to have

• Advanced degree such as MS, PhD, MD, DVM, or an MBA.
• Experience leading teams, preferably for 5 years.
• Background working in a complex, matrixed environment.

What the company offers

• Access to information regarding CSL benefits and well-being support programs.

About the company

CSL Behring is a global leader in biotherapeutics, driven by a mission to save lives. The company discovers, develops, and delivers innovative therapies for conditions in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant areas. CSL operates one of the world’s largest plasma collection networks, CSL Plasma, and fosters a culture of curiosity and empathy to better understand patients and donors. Inclusion and Belonging are core to CSL’s mission, fueling innovation and growth.

• Global biotherapeutics leader focused on saving lives.
• Innovative therapies for immunology, hematology, cardiovascular, metabolic, respiratory, and transplant conditions.
• Operates CSL Plasma, one of the world’s largest plasma collection networks.
• Core values of Inclusion and Belonging drive innovation.
• Culture of curiosity and empathy to understand patients and donors.