Director, Sr. Global Regulatory Lead - Cardiorenal
CSL SEQIRUS
10 years in biotech or pharmaceutical industry
8 years in regulatory affairs experience
5 years with developmental products
The role involves developing a global, integrated regulatory strategy ensuring scientifically sound approaches for assigned products from early development through post-marketing lifecycle
Job Summary
The role involves developing a global, integrated regulatory strategy ensuring scientifically sound approaches for assigned products from early development through post-marketing lifecycle.
Candidates must act as the single GRA representative for Product Strategy Teams while leading the Global Regulatory Affairs Strategy Team to ensure alignment and a unified voice.
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 platforms.
Matching Summary
The role involves developing a global, integrated regulatory strategy ensuring scientifically sound approaches for assigned products from early development through post-marketing lifecycle.
Skills & Requirements
Must-have
10 years in biotech or pharmaceutical industry
8 years in regulatory affairs experience
5 years with developmental products
Direct interaction with FDA or EMA health authorities
Leading cross-functional Product Strategy Teams
Nice-to-have
Experience in complex matrix environment
MBA or advanced degree preferred
Knowledge of EU, US, and Japan regulatory requirements
Fostering team collaboration and accountability
Coaching team members for innovative solutions
Key Requirements
Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science
Minimum 10 years total industry experience
At least 5 years of team leadership experience
Advanced degree (MS, PhD, MD, DVM) or MBA preferred
Proven track record of managing strategic relationships with health authorities