STADA Arzneimittel AG
Senior Director Regulatory Global Specialty / Biosimilar Development(m/w/x)
Vollzeit/Teilzeit
mit Homeoffice
Senior
Keine Angabe
Bad Vilbel
ST
STADA Arzneimittel AG17 Stunden
Senior Director Regulatory Global Specialty / Biosimilar Development(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
61118 Bad Vilbel
Nejo KI-Zusammenfassung
In this role, you will oversee regulatory operations while leading a team to align efforts with strategic goals. Your day-to-day responsibilities will involve engaging with health authorities, monitoring regulatory trends, and ensuring the timely delivery of essential documents.
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Anforderungen
- •Master or PhD in Life Science
- •15+ years of experience in Pharmaceutical industry and 8+ years in Regulatory affairs
- •Proven track record of achieving drug approvals from health authorities
- •Broad coverage of regulatory topics from CMC, Clinical, Devices, labelling, pre-approval inspections
- •Proven track record as team leader in line or matrix setting
- •Robust understanding of Biologics, recombinant molecules, and ideally Biosimilars
- •Experienced user of regulatory intelligence software, publishing tools, and document management software
- •Team player in global and cross-functional environments
- •Entrepreneurial with proactive and agile working style
- •Open-minded and curious to explore new ways of working
- •Excellent knowledge in English, any other language(s) like German are a plus
Master-Abschluss
ODER
Doktor / Ph.D.
Berufserfahrung
15 Jahre
Deine Aufgaben
- •Oversee all regulatory aspects of the department
- •Act as deputy to the Head of Global Specialty Development
- •Lead the team to drive strategic direction
- •Define clear roles and responsibilities for team members
- •Align individual deliverables with departmental objectives
- •Establish relevant KPIs to track regulatory performance
- •Oversee regulatory activities, including due diligence contributions
- •Prepare for and participate in regulatory interactions with health authorities
- •Ensure timely delivery of high-quality regulatory documents for new applications
- •Manage lifecycle activities for post-approval variations and submissions
- •Monitor new regulatory trends and guidelines
- •Translate regulatory trends into impact assessments for the business
- •Implement best-in-class tools and processes for the department
- •Act as a sparring partner for strategic discussions on Specialty & Biosimilar assets
- •Represent Global Specialty/Biosimilar development in management boards
- •Serve as the go-to expert for global and local regulatory questions
Tools & Technologien
regulatory intelligence softwarepublishing toolsdocument management software
Sprachen
Englisch – verhandlungssicher
Deutsch – Grundkenntnisse
Deine Vorteile
Flexibles Arbeiten
- •Flexible working hours
- •Mobile working up to 2 days per week
Lockere Unternehmenskultur
- •Open corporate culture
Weiterbildungsangebote
- •Individual development opportunities
Öffi Tickets
- •Job ticket for RMV region
Firmenfahrrad
- •Job Bike
Sonstige Zulagen
- •Childcare allowance
Gesundheits- & Fitnessangebote
- •Health-promoting offers
Sonstige Vorteile
- •Group accident insurance
Betriebliche Altersvorsorge
- •Supplementary pension scheme
Gratis oder Vergünstigte Mahlzeiten
- •Subsidized cafeteria
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens STADA Arzneimittel AG 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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