CSL Behring L.L.C.
APAC/LATAM Regulatory Affairs Hematology Lead (Senior Director)(m/w/x)
Vollzeitnur vor OrtSenior
Glattbrugg
Neuer Job?Nejo!
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CSCSL Behring L.L.C.
Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Glattbrugg
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- 12 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Gesundheits- & Fitnessangebote
- Health care resources
Sonstige Vorteile
- Financial protection resources
- Financial planning resources
Kinderbetreuung
- Emergency backup care assistance
- Summer camp assistance
Mentale Gesundheitsförderung
- Mental health resources
Gemeinnützige Ausrichtung
- Charity matching contribution
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring L.L.C. erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- CSL Behring AG (CH)
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Vollzeitnur vor OrtSeniorZürich - CSL Behring
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CSCSL Behring L.L.C.
Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Glattbrugg
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- 12 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Gesundheits- & Fitnessangebote
- Health care resources
Sonstige Vorteile
- Financial protection resources
- Financial planning resources
Kinderbetreuung
- Emergency backup care assistance
- Summer camp assistance
Mentale Gesundheitsförderung
- Mental health resources
Gemeinnützige Ausrichtung
- Charity matching contribution
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring L.L.C. erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
CSL Behring L.L.C.
Branche
Pharmaceuticals
Beschreibung
The company is a global biotherapeutics leader focused on developing innovative therapies for various medical conditions.
Noch nicht perfekt?
- CSL Behring L.L.C.
APAC/LATAM Regulatory Affairs Hematology Lead (Senior Director)(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg - CSL Behring AG (CH)
Regional Regulatory Lead – APAC, LATAM & Partner Business(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg - Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - Oncology(m/w/x)
Vollzeitnur vor OrtSeniorZürich - CSL Behring
Senior Director, Head of Translational Research Hematology & CVR(m/w/x)
Vollzeitnur vor OrtManagementSchlieren - Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - GI and Inflammation(m/w/x)
Vollzeitnur vor OrtSeniorZürich