Director, Sr. Global Regulatory Lead - Cardiorenal
CSL Behring
10 years biotech or pharmaceutical experience
8 years regulatory affairs experience
5 years developmental product experience
The role involves developing a global, integrated regulatory strategy ensuring innovative approaches for assigned products from early development through post-marketing lifecycle activities
Job Summary
The role involves developing a global, integrated regulatory strategy ensuring innovative approaches for assigned products from early development through post-marketing lifecycle activities.
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 regulatory voice.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives, utilizing plasma fractionation, recombinant protein technology, and cell and gene therapy platforms.
Matching Summary
The role involves developing a global, integrated regulatory strategy ensuring innovative approaches for assigned products from early development through post-marketing lifecycle activities.
Skills & Requirements
Must-have
10 years biotech or pharmaceutical experience
8 years regulatory affairs experience
5 years developmental product experience
FDA and EMA interaction experience
Team leadership and decision-making skills
Nice-to-have
Advanced degree in life sciences or MBA
Experience in complex matrix environment
Mentoring and talent development capabilities
Patient-centric regulatory approach
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 experience leading teams
Knowledge of regulatory requirements across EU, US, and Japan