Director, Sr. Global Regulatory Lead - Cardiorenal
CSL
10 years biotech or pharmaceutical industry experience
8 years regulatory affairs experience
5 years developmental products experience
The role requires developing a global, integrated regulatory strategy ensuring innovative approaches for assigned products from early development through post-marketing
Job Summary
The role requires developing a global, integrated regulatory strategy ensuring innovative approaches for assigned products from early development through post-marketing.
Candidates must act as the single GRA representative for Product Strategy Teams while leading the Global Regulatory Affairs Strategy Team to ensure alignment.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives using plasma fractionation, recombinant protein technology, and cell and gene therapy.
Matching Summary
The role requires developing a global, integrated regulatory strategy ensuring innovative approaches for assigned products from early development through post-marketing.
Skills & Requirements
Must-have
10 years biotech or pharmaceutical industry experience
8 years regulatory affairs experience
5 years developmental products experience
Direct interaction with FDA or EMA
Leading cross-functional strategic teams
Nice-to-have
Experience in complex matrix environment
MBA or advanced life science degree
Knowledge of EU, US, and Japan regulations
Talent development and succession planning skills
Key Requirements
Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science
Minimum 10 years in biotech or pharmaceutical industry
At least 5 years of team leadership experience
Advanced degree (MS, PhD, MD, DVM) or MBA preferred