Director Regulatory Global Specialty

vor 5 Monaten

Bad Vilbel, Deutschland STADA Arzneimittel AG Vollzeit

Patienten, Ärzte und Apotheker stehen im Mittelpunkt unseres Denkens und Handelns. An ihren Bedürfnissen orientieren wir uns. Mit unseren Spezialpharmazeutika und Biosimilars eröffnen wir schwer und chronisch erkrankten Patienten Zugang zu hochwirksamen, wirtschaftlichen Behandlungsmöglichkeiten. Mit innovativen Therapie
- und Service-Angeboten in Bereichen wie Neurologie, Nephrologie, Onkologie und Schmerz bietet STADAPHARM Patienten und deren Angehörigen optimale Unterstützung und ein Stück Lebensqualität.- Genau wie unsere rund 13.000 STADA-Kolleginnen und -Kollegen weltweit motiviert uns unser Auftrag „Caring for People’s Health as a Trusted Partner“ jeden Tag aufs Neue, unser Bestes zu geben und STADAs Wachstumskurs fortzusetzen.- Du möchtest Teil eines dynamischen Teams werden und gemeinsam mit uns einen Beitrag zur Gesundheit der Menschen in Deutschland leisten? Dann bewirb Dich jetzt auf die Stelle als:
**Director Regulatory Global Specialty / Biosimilar Development**
- Bad Vilbel | Deutschland (DE) | Vollzeit | Unbefristet**What you can expect**:

- Team Leader Responsibility
- Definition of clear roles and responsibilities for individual team members
- Definition and prioritization of individual deliverables across the department, closely aligned with overarching department objectives
- Development of individuals incl. performance reviews and development plans
- Assure overall team performance and bandwidth of team’s skill set, in particular communication skills, both verbally and in writing, project management skills, and strategic thinking
- Definition of relevant KPIs for Regulatory department to assure consistent performance tracking
- Accountability for all Regulatory aspects of the Department
- Oversight of all regulatory activities incl.
- Contribution to due diligences if applicable
- Preparation of and participation in all regulatory interactions with Health authorities incl. local bodies
- Close monitoring of new regulatory trends, guidance and guidelines and translation into potential impact assessment on STADA Specialty and Biosimilar business
- Development and implementation on state-of-the art processes
- Identification and implementation of best-in-class tools to support the department and the team
- Sparring partner for VP Global Specialty Development in strategic discussion on Specialty & Biosimilar assets
- Representative of STADA Global Specialty/Biosimilar development in management boards as required, both internally but also with external, (co)-collaboration partners
- Go-to expert for all kind of global & local Regulatory questions Deputy
- Deputy of Head Global Specialty Development

**Who we are looking for**:

- Master in Life Science, Ph.D.
- 15+ years of experience in Pharmaceutical industry
- 8 + years of experience in Regulatory affairs incl. global positions
- Proven track record of achieving drug approvals from different health authorities, in particular FDA, EMA, Swissmedic, additional experience with e.g. COFEPRIS, ANVISA, PMDA, NMPA, etc. is a plus
- Broad coverage of regulatory topics from CMC, Clinical, Devices, labelling, pre-approval inspections, etc.
- Proven track record as team leader either in line or matrix setting
- Robust understanding of Biologics / recombinant molecules, ideally also Biosimilars
- Experienced user of regulatory intelligence software, publishing tools and document management software (preparation of eCTDs)
- Strong communicator, both verbally and in writing
- Team player, proven to be successfully working in global and cross-functional environments
- Entrepreneur with proactive and agile working style - resilient in facing ambiguity at the same time efficiently deploying project management skills
- Open-minded and curious to explore new ways of working
- Excellent knowledge in English, any other language(s) is (are) a plus

**Was wir bieten**
- Eine offene Unternehmenskultur mit kurzen Abstimmungswegen und viel Potenzial für Deine persönliche Entwicklung
- Individuelle Fort
- und Weiterbildungsangebote
- Flexible Arbeitszeitmodelle und mobiles Arbeiten an bis zu 2 Tagen pro Woche (abhängig vom Stellenprofil)
- Job-Ticket für das RMV-Gebiet
- Job-Bike
- Zuschuss zur Kinderbetreuung
- Gesundheitsfördernde Angebote wie Wellpass und ein Fitnessstudio zur kostenfreien Nutzung
- Zahlreich attraktive Zusatzleistungen wie Zukunftsbetrag für Tarifmitarbeiter, Gruppenunfallversicherung, Alterszusatzversorgung und Altersvorsorge Chemie-Pensionsfonds
- Bezuschusste Kantine- STADA Group fördert seine vielfältige Kultur, unabhängig von Geschlecht, Alter, sozialer oder ethnischer Herkunft, Behinderung, Religion, Weltanschauung oder sexueller Orientierung. Wir nutzen die Stärke dieser Vielfalt, um kreative Ideen zu entwickeln, unsere Erfahrungen zu erweitern und die Innovationskraft zu steigen. Unser Fokus liegt dabei auf Chancengleichheit, einem respektvollen Miteinander sowie der Förderung eines integrativen Arbeitsumfeld

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