CSL Behring L.L.C.
APAC/LATAM Regulatory Affairs Hematology Lead (Senior Director)(m/w/x)
Full-timeOn-siteSenior
Glattbrugg
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CSCSL Behring L.L.C.
Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Glattbrugg
Full-timeOn-siteSenior
Nejo AI Summary
Developing global regulatory strategies for hematology biotherapeutics, leading health authority interactions with FDA/EMA at a global biotherapeutics leader. 10 years in Regulatory Affairs and 7 years of team leadership required. Emergency backup care and summer camp assistance.
Requirements
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science
- Advanced degree in a related field (MS, PhD, MD, DVM) or MBA preferred
- Minimum of 12 years’ experience in biotech or pharmaceutical industry
- At least 10 years in Regulatory Affairs
- Minimum 7 years of experience in leading and managing teams
- Thorough knowledge of pharmaceutical/biological product development and regulatory requirements
- Experience in Regulatory Affairs with direct agency interaction responsibility
- Experience working in a complex and matrix environment
- Strong clinical or device foundation
- Strong ethics and integrity
- Strategic thinking and risk management
- Effective communication skills
- Ability to build productive working relationships
- Fluency in English (verbal and written)
Tasks
- Develop global regulatory strategies for assigned portfolio
- Ensure timely delivery of successful regulatory outcomes
- Lead health authority interactions with FDA and EMA
- Build productive relationships with global health authorities
- Lead a team of Global and Regional Regulatory Leads
- Coach team members for effective talent development
- Foster relationships with Product Strategy and Clinical Development teams
- Engage GRAST members to achieve regulatory deliverables
- Encourage robust regulatory scenario assessments
- Mentor team members in innovative solution development
- Review and approve regulatory deliverables from various teams
- Participate in regulatory due diligence activities as needed
- Lead discussions at the Global Regulatory Forum
- Apply CSL Leadership Capabilities to mentor the team
- Represent CSL in industry association initiatives
Work Experience
- 12 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Healthcare & Fitness
- Health care resources
Other Benefits
- Financial protection resources
- Financial planning resources
Childcare
- Emergency backup care assistance
- Summer camp assistance
Mental Health Support
- Mental health resources
Social Impact
- Charity matching contribution
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring L.L.C. 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.
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CSCSL Behring L.L.C.
Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Glattbrugg
Full-timeOn-siteSenior
Nejo AI Summary
Developing global regulatory strategies for hematology biotherapeutics, leading health authority interactions with FDA/EMA at a global biotherapeutics leader. 10 years in Regulatory Affairs and 7 years of team leadership required. Emergency backup care and summer camp assistance.
Requirements
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science
- Advanced degree in a related field (MS, PhD, MD, DVM) or MBA preferred
- Minimum of 12 years’ experience in biotech or pharmaceutical industry
- At least 10 years in Regulatory Affairs
- Minimum 7 years of experience in leading and managing teams
- Thorough knowledge of pharmaceutical/biological product development and regulatory requirements
- Experience in Regulatory Affairs with direct agency interaction responsibility
- Experience working in a complex and matrix environment
- Strong clinical or device foundation
- Strong ethics and integrity
- Strategic thinking and risk management
- Effective communication skills
- Ability to build productive working relationships
- Fluency in English (verbal and written)
Tasks
- Develop global regulatory strategies for assigned portfolio
- Ensure timely delivery of successful regulatory outcomes
- Lead health authority interactions with FDA and EMA
- Build productive relationships with global health authorities
- Lead a team of Global and Regional Regulatory Leads
- Coach team members for effective talent development
- Foster relationships with Product Strategy and Clinical Development teams
- Engage GRAST members to achieve regulatory deliverables
- Encourage robust regulatory scenario assessments
- Mentor team members in innovative solution development
- Review and approve regulatory deliverables from various teams
- Participate in regulatory due diligence activities as needed
- Lead discussions at the Global Regulatory Forum
- Apply CSL Leadership Capabilities to mentor the team
- Represent CSL in industry association initiatives
Work Experience
- 12 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Healthcare & Fitness
- Health care resources
Other Benefits
- Financial protection resources
- Financial planning resources
Childcare
- Emergency backup care assistance
- Summer camp assistance
Mental Health Support
- Mental health resources
Social Impact
- Charity matching contribution
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring L.L.C. 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 L.L.C.
Industry
Pharmaceuticals
Description
The company is a global biotherapeutics leader focused on developing innovative therapies for various medical conditions.
Not a perfect match?
- CSL Behring L.L.C.
APAC/LATAM Regulatory Affairs Hematology Lead (Senior Director)(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - CSL Behring AG (CH)
Regional Regulatory Lead – APAC, LATAM & Partner Business(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - Oncology(m/w/x)
Full-timeOn-siteSeniorZürich - CSL Behring
Senior Director, Head of Translational Research Hematology & CVR(m/w/x)
Full-timeOn-siteManagementSchlieren - Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - GI and Inflammation(m/w/x)
Full-timeOn-siteSeniorZürich