Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe
CSL Innovation(3 months ago)
About this role
A senior regulatory leader within CSL’s Global Regulatory Strategy Leads Team responsible for defining and aligning integrated, patient‑centric regulatory strategies across product lifecycles. Serves as the primary Global Regulatory Affairs representative to Product Strategy Teams and leads direct interactions with major health authorities (e.g., FDA, EMA). Oversees a global team of regulatory leads and ensures cross‑functional alignment with R&D and commercial partners.
Required Skills
- Regulatory Strategy
- Health Authorities
- Team Leadership
- Lifecycle Management
- Stakeholder Engagement
- Risk Assessment
- Regulatory Submissions
- Clinical Development
- Communication Skills
- Talent Development
Qualifications
- Bachelor's Degree in Life Science
- MS
- PhD
- MD
- DVM
- MBA
About CSL Innovation
csl.comCSL is a leading global biotechnology company dedicated to creating lifesaving medicines. With a portfolio that includes therapies for rare diseases, immune deficiencies, and vaccines for influenza, CSL's mission is rooted in innovation and public health. The organization comprises three distinct businesses: CSL Behring, focused on plasma-derived therapies; CSL Seqirus, specializing in influenza vaccines; and CSL Vifor, addressing iron deficiency and nephrology. Since its founding in 1916, CSL has been committed to ensuring access to essential treatments for patients in over 100 countries.
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