Director, Sr. Global Regulatory Lead - Cardiorenal
Century Center
10 years biotech or pharmaceutical industry 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.
As the single GRA representative, the incumbent leads health authority interactions with the FDA and EMA to drive positive regulatory outcomes globally.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives, utilizing plasma fractionation and recombinant protein technologies.
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 industry experience
8 years regulatory affairs experience
5 years developmental product experience
FDA and EMA health authority interaction
Leading cross-functional global teams
Nice-to-have
Experience in complex matrix environment
MBA or advanced life science degree preferred
Talent development and succession planning skills
Patient-centric regulatory approach
Strategic risk-taking capabilities
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
Direct experience interacting with at least one health authority