Director, Sr. Global Regulatory Lead - Cardiorenal
Seqirus
10 years biotech or pharmaceutical industry experience
8 years regulatory affairs experience
5 years developmental products experience
The role requires developing a global, integrated regulatory strategy ensuring innovative approaches for assigned products from early development through post-marketing
Job Summary
The role requires developing a global, integrated regulatory strategy ensuring innovative approaches for assigned products from early development through post-marketing.
Candidates must act as the single GRA representative for Product Strategy Teams while leading the Global Regulatory Affairs Strategy Team to ensure alignment.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives using advanced technologies like plasma fractionation and cell therapy.
Matching Summary
The role requires developing a global, integrated regulatory strategy ensuring innovative approaches for assigned products from early development through post-marketing.
Skills & Requirements
Must-have
10 years biotech or pharmaceutical industry experience
8 years regulatory affairs experience
5 years developmental products experience
FDA and EMA interaction experience
Team leadership in matrix environment
Nice-to-have
Advanced degree in life sciences or MBA
Experience with plasma fractionation technologies
Strong patient-centric focus
Inclusive culture and belonging mindset
Key Requirements
Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science
Minimum 10 years in biotech or pharmaceutical industry