Director, Sr. Global Regulatory Lead - Cardiorenal
CSL Behring
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 with a patient-centric focus to achieve successful outcomes from early development through post-marketing lifecycle activities
Job Summary
The role involves developing a global, integrated regulatory strategy with a patient-centric focus to achieve successful outcomes from early development through post-marketing lifecycle activities.
As the single GRA representative, the incumbent leads health authority interactions with the FDA and EMA while managing the Global Regulatory Affairs Strategy Team to ensure alignment.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives, utilizing advanced technologies to deliver innovative therapies across multiple therapeutic areas.
Matching Summary
The role involves developing a global, integrated regulatory strategy with a patient-centric focus to achieve successful outcomes 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 global regulatory strategy teams
Nice-to-have
Experience in complex matrix environment
Advanced degree in life sciences or MBA
Mentoring and talent development skills
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