Director, Sr. Global Regulatory Lead - Cardiorenal
CSL Behring
Global regulatory strategy development
Fda and ema health authority interaction
Leading cross-functional product teams
The role involves developing a global, integrated regulatory strategy with a patient-centric focus for assigned products from early development through post-marketing lifecycle activities
Job Summary
The role involves developing a global, integrated regulatory strategy with a patient-centric focus for assigned products from early development through post-marketing lifecycle activities.
The incumbent acts as the single GRA representative for Product Strategy Teams and leads 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 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 for assigned products from early development through post-marketing lifecycle activities.
Skills & Requirements
Must-have
Global regulatory strategy development
FDA and EMA health authority interaction
Leading cross-functional product teams
Regulatory document preparation and approval
Strategic planning for developmental products
Nice-to-have
Experience in complex matrix environments
Mentoring and team development skills
Knowledge of EU, US, and Japan regulations
Innovative problem-solving capabilities
Key Requirements
Bachelor's degree in pharmacy, biology, chemistry, or related life science
Minimum 10 years in biotech or pharmaceutical industry