Director, Sr. Global Regulatory Lead - Cardiorenal
cslseqirus.co.nz
Not specified
Global regulatory strategy development
Health authority interactions (fda, ema)
Product strategy team leadership
CSL Behring is seeking a Director, Senior Global Regulatory Lead for their Global Regulatory Strategy team, focusing on developing regulatory strategies for cardiorenal products. The ideal candidate will have extensive experience in regulatory affairs and a strong background in biotech or pharmaceuticals, with a focus on collaboration and relationship-building with health authorities
Job Summary
Develops a global, integrated regulatory strategy ensuring innovative and scientifically sound regulatory approaches for assigned products, with a patient-centric focus and appropriate risk-taking to achieve successful regulatory outcomes from early development through post-marketing lifecycle activities.
Acts as a key member and single GRA representative for Product Strategy Teams (PST) and related global R&D/commercial teams, while leading the Global Regulatory Affairs Strategy Team (GRAST) to ensure alignment and a unified regulatory voice.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.
Matching Summary
Match Score: 85
CSL Behring is seeking a Director, Senior Global Regulatory Lead for their Global Regulatory Strategy team, focusing on developing regulatory strategies for cardiorenal products. The ideal candidate will have extensive experience in regulatory affairs and a strong background in biotech or pharmaceuticals, with a focus on collaboration and relationship-building with health authorities.
Skills & Requirements
Must-have
Global regulatory strategy development
Health authority interactions (FDA, EMA)
Product Strategy Team leadership
Regulatory affairs strategy
Patient-centric regulatory approaches
Nice-to-have
Talent development and succession planning
Cross-functional collaboration and knowledge sharing
Innovative solutions development
Inclusion and Belonging culture
Key Requirements
Bachelor's degree in life science
10+ years in biotech/pharma
8+ years in regulatory affairs
5+ years with developmental products
5 years leading teams
Knowledge of EU, US, Japan regulatory requirements