CSL Behring L.L.C.
APAC/LATAM Regulatory Affairs Hematology Lead (Senior Director)(m/w/x)
Vollzeit
Senior
Keine Angabe
Glattbrugg
CS
CSL Behring L.L.C.1 Monat
Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Vollzeit
Senior
Keine Angabe
8152 Glattbrugg
Nejo KI-Zusammenfassung
In this role, you will lead the development of global regulatory strategies while collaborating with various teams to ensure successful outcomes. Your day-to-day responsibilities will involve engaging with health authorities, mentoring your team, and driving innovative solutions to bring therapies to patients.
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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)
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
12 Jahre
Deine 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
Sprachen
Englisch – verhandlungssicher
Deine Vorteile
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.
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