CSL Behring L.L.C.
Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Full-timeOn-siteSenior
Glattbrugg
New Job?Nejo!
Your personal AI career agent
CSCSL Behring
Director, Sr. Global Regulatory Lead - Cardiorenal(m/w/x)
Glattbrugg
Full-timeOn-siteSenior
Nejo AI Summary
Developing global regulatory strategies for cardiorenal therapies, focusing on patient-centricity and risk-taking. Advanced degree and 8+ years in regulatory affairs required. Hybrid work, 6 weeks vacation.
Requirements
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science
- Advanced degree (MS, PhD, MD, DVM) or MBA preferred
- Minimum 10 years in biotech or pharmaceutical industry
- At least 8 years in regulatory affairs
- 5 years with developmental products
- Experience leading teams (preferably 5 years)
- Decision-making skills
- Fostering collaboration skills
- Knowledge of product development
- Knowledge of regulatory requirements across major regions (EU, US, Japan)
- Experience interacting directly with at least one health authority
- Experience working in a complex, matrix environment preferred
Tasks
- Develop global, integrated regulatory strategies
- Ensure scientifically sound regulatory approaches
- Focus on patient-centricity and risk-taking
- Achieve successful regulatory outcomes
- Act as GRA representative for Product Strategy Teams
- Lead Global Regulatory Affairs Strategy Teams
- Ensure unified regulatory voice
- Lead health authority interactions
- Build productive health authority relationships
- Drive positive global regulatory outcomes
- Engage GRAST members for regulatory outputs
- Foster accountability and collaboration within GRAST
- Approve regulatory deliverables
- Ensure strong communication between regulatory and R&D
- Manage Regional Regulatory Leads (for selected roles)
- Support development of Regional Regulatory Leads
- Build strong relationships with Product Strategy Teams
- Build strong relationships with Clinical Development Teams
- Build strong relationships with Safety Management Teams
- Ensure effective collaboration with stakeholders
- Manage strategic relationships with key health authorities
- Coordinate regional leads for non-home country interactions
- Act as single GRA reviewer/approver for key deliverables
- Participate in regulatory due diligence
- Participate in senior-level discussions
- Lead preparation of key regulatory documents
- Mentor GRAST members
- Utilize regulatory intelligence for strategies
- Utilize analytics for strategies
- Utilize cross-functional expertise for strategies
- Promote consistency across GRS teams
- Promote collaboration across GRS teams
- Promote knowledge sharing across GRS teams
- Coach team members on innovative solutions
- Ensure timely execution of regulatory strategies
- Apply CSL leadership capabilities
- Support talent development
- Support succession planning
- Support team empowerment
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
- CSL Behring
Senior Director Global Clinical Program Lead Cardiovascular & Renal(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - CSL Behring L.L.C.
APAC/LATAM Regulatory Affairs Hematology Lead (Senior Director)(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - GI and Inflammation(m/w/x)
Full-timeOn-siteSeniorZürich - Takeda Pharmaceuticals International AG
GRA CMC Director - Marketed Products Development Lead(m/w/x)
Full-timeOn-siteManagementZürich
CSCSL Behring
Director, Sr. Global Regulatory Lead - Cardiorenal(m/w/x)
Glattbrugg
Full-timeOn-siteSenior
Nejo AI Summary
Developing global regulatory strategies for cardiorenal therapies, focusing on patient-centricity and risk-taking. Advanced degree and 8+ years in regulatory affairs required. Hybrid work, 6 weeks vacation.
Requirements
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science
- Advanced degree (MS, PhD, MD, DVM) or MBA preferred
- Minimum 10 years in biotech or pharmaceutical industry
- At least 8 years in regulatory affairs
- 5 years with developmental products
- Experience leading teams (preferably 5 years)
- Decision-making skills
- Fostering collaboration skills
- Knowledge of product development
- Knowledge of regulatory requirements across major regions (EU, US, Japan)
- Experience interacting directly with at least one health authority
- Experience working in a complex, matrix environment preferred
Tasks
- Develop global, integrated regulatory strategies
- Ensure scientifically sound regulatory approaches
- Focus on patient-centricity and risk-taking
- Achieve successful regulatory outcomes
- Act as GRA representative for Product Strategy Teams
- Lead Global Regulatory Affairs Strategy Teams
- Ensure unified regulatory voice
- Lead health authority interactions
- Build productive health authority relationships
- Drive positive global regulatory outcomes
- Engage GRAST members for regulatory outputs
- Foster accountability and collaboration within GRAST
- Approve regulatory deliverables
- Ensure strong communication between regulatory and R&D
- Manage Regional Regulatory Leads (for selected roles)
- Support development of Regional Regulatory Leads
- Build strong relationships with Product Strategy Teams
- Build strong relationships with Clinical Development Teams
- Build strong relationships with Safety Management Teams
- Ensure effective collaboration with stakeholders
- Manage strategic relationships with key health authorities
- Coordinate regional leads for non-home country interactions
- Act as single GRA reviewer/approver for key deliverables
- Participate in regulatory due diligence
- Participate in senior-level discussions
- Lead preparation of key regulatory documents
- Mentor GRAST members
- Utilize regulatory intelligence for strategies
- Utilize analytics for strategies
- Utilize cross-functional expertise for strategies
- Promote consistency across GRS teams
- Promote collaboration across GRS teams
- Promote knowledge sharing across GRS teams
- Coach team members on innovative solutions
- Ensure timely execution of regulatory strategies
- Apply CSL leadership capabilities
- Support talent development
- Support succession planning
- Support team empowerment
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
CSL Behring
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
Not a perfect match?
- CSL Behring L.L.C.
Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - CSL Behring
Senior Director Global Clinical Program Lead Cardiovascular & Renal(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - CSL Behring L.L.C.
APAC/LATAM Regulatory Affairs Hematology Lead (Senior Director)(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - GI and Inflammation(m/w/x)
Full-timeOn-siteSeniorZürich - Takeda Pharmaceuticals International AG
GRA CMC Director - Marketed Products Development Lead(m/w/x)
Full-timeOn-siteManagementZürich