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Regulatory affairs director Jobs in Niddatal

Zuletzt aktualisiert: vor 1 Tag
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Senior Director Regulatory Affairs (f / m / d)

Senior Director Regulatory Affairs (f / m / d)

STADA Arzneimittel AGBad Vilbel, DE
Caring for People's Health as a Trusted Partner" - This mission motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products a...Mehr anzeigenZuletzt aktualisiert: vor 20 Tagen
Strategy Director (m / w / d)

Strategy Director (m / w / d)

CareerTeamHessen
Zusammen mit einer Media Agentur aus Hessen suchen wir eine : n Strategy Director (m / w / d).Es handelt sich um eine Fullservice-Agentur, die alle Bereiche der modernen Kommunikation abdeckt und integri...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
(Senior) Consultant Product Security & Secure Development (m / f / d)

(Senior) Consultant Product Security & Secure Development (m / f / d)

FRESENIUS_SEBad Homburg
We are the Product Security team at Fresenius and are part of the Group Cybersecurity Office (GCSO).You know that securing digital value creation is a multifaceted task? You are technically enthusi...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Creative Director Industriedesign (m / w / d)

Creative Director Industriedesign (m / w / d)

König + NeurathKarben
Verantwortliche Entwicklung und Umsetzung der Designstrategie für unsere Produktpalette in enger Zusammenarbeit mit Produktmanagement, Entwicklung, Vertrieb und Produktion.Durchführung von Markt- u...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Bankaufsichtsrecht / Finance Regulatory 6+ bis Partner •in

Bankaufsichtsrecht / Finance Regulatory 6+ bis Partner •in

Schollmeyer&SteidlHessen
Besetzen Sie eine echte strategische Lücke! Diese US Kanzlei baut in Deutschland dezidiert weiter aus.Im Banking Finance entwickelt sich international und national das Geschäft auf hohem Niveau for...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Director Legal Compliance EMEA

Director Legal Compliance EMEA

CarrierHesse, Germany
Vollzeit
Viessmann Werke Allendorf GmbH, Viessmannstraße 1, 35107 Allendorf (Eder), Germany.Director Legal Compliance EMEA.Rueil-Malmaison, France or Allendorf, Germany. Carrier is the leading global provide...Mehr anzeigenZuletzt aktualisiert: vor 8 Tagen
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Director Workplace Experience DACH (m / w / d)

Director Workplace Experience DACH (m / w / d)

MPHessen, Germany
Das Unternehmen ist ein global führender Anbietervon Immobilienberatung und -management, welches stets nacheffizienten, nachhaltigen und strategisch optimiertenImmobilienlösungen sucht.Förderung vo...Mehr anzeigenZuletzt aktualisiert: vor 2 Tagen
Platform Projects Director (m / f / d)

Platform Projects Director (m / f / d)

ValeoFriedrichsdorf
Vollzeit
Lead operationally and functionally a portfolio of all Projects dedicated to a Product technology portfolio which can involve many entities of the Product Line. Programs concerning the entity.Progra...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Director Portfolio Management Energy - Renewables & Power - Wholesale Banking (w / m / d)

Director Portfolio Management Energy - Renewables & Power - Wholesale Banking (w / m / d)

ING DiBaBad Homburg
Wertschätzender Dialog und effektiver Austausch – extern wie intern – sind Deine Schlüssel zum Erfolg : Du stehst in engem Kontakt sowohl mit Kunden als auch mit den Kundenbetreuer •innen und int...Mehr anzeigenZuletzt aktualisiert: vor 5 Tagen
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Referent Regulatory Reporting (w / m / d)

Referent Regulatory Reporting (w / m / d)

ING DeutschlandBad Homburg
Referent Regulatory Reporting (w / m / d) am Standort Frankfurt Regularien, Anforderungen, Vorschriften - Du navigierst ihre komplexen Zusammenhänge souverän? Dein waches Auge erkennt Details und inno...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Creative Director Industriedesign (m / w / d)

Creative Director Industriedesign (m / w / d)

König + Neurath AGKarben, Hessen, Deutschland
Quick Apply
Creative Director Industriedesign (m / w / d) bei König + Neurath AG | softgarden.Gestalte innovative Arbeitswelten mit uns und werde Teil unserer WIR-Kultur!Die König + Neurath AG ist führender Herste...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Director Workplace Experience Dach (m / w / d)

Director Workplace Experience Dach (m / w / d)

Michael PageNot Specified, Hessen, Germany
Das Unternehmen ist ein global führender Anbieter von Immobilienberatung und -management, welches stets nach effizienten, nachhaltigen und strategisch optimierten Immobilienlösungen sucht.Der Anbie...Mehr anzeigenZuletzt aktualisiert: vor 1 Tag
Regulatory Affairs Specialist (m / w / d)

Regulatory Affairs Specialist (m / w / d)

BertrandtFriedberg
Sie sind für die Abwicklung der Zulassungen von aktiven und inaktiven internationalen Medizinprodukten zuständig.Sie kümmern sich um die Dokumentation der Ergebnisse sowie die Pflege der regulatori...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Director RWD Scientist

Director RWD Scientist

SEC Life SciencesHessen
Unbefristet
Are you ready to shape the future of healthcare through cutting-edge data analytics? We are seeking a dynamic.Director, Real World Data (RWD) Scientist. This is an exciting opportunity to leverage y...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Director of Operations

Director of Operations

Fresenius Medical CareBad Homburg, Frankfurt
Acts as a serving leader to direct, administer and oversee the day to day operations and activities of dialysis facilities and programs within a specified and potentially changing geographic proxim...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regulatory Affairs CMC Lead - Biosimilars (m / f / d)

Regulatory Affairs CMC Lead - Biosimilars (m / f / d)

FRESENIUS_KABIBad Homburg
Lead and manage CMC regulatory activities related to Biosimilars for development, initial MAA / BLA registration and post approval life cycle management (LCM) worldwide. Define the RA-CMC strategy for...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regulatory Affairs Manager in Vollzeit (m / w / d)

Regulatory Affairs Manager in Vollzeit (m / w / d)

DQS GmbHBad Vilbel
Entdecken Übersicht Nachhaltigkeit Qualitäts­management Integriertes Management­system Medizinprodukte Informations­sicherheit Food & Consumer. Mitarbeiten Übersicht Stellenanzeigen Freie Mitarbeite...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Medical Affairs Lead (m / f / d) Oncology

Medical Affairs Lead (m / f / d) Oncology

LillyBAD HOMBURG, Hesse, Germany
Vollzeit
We’re looking for people who are determined to make life better for people around the world.Lilly has a long history of research / development in the therapy area of Oncology, and of bringing innovat...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Senior Director Regulatory Affairs (f / m / d)

Senior Director Regulatory Affairs (f / m / d)

STADA Arzneimittel AGBad Vilbel, DE
Vor 20 Tagen
Stellenbeschreibung

Caring for People's Health as a Trusted Partner" - This mission motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options.

Around 11,700 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.

Do you want to become part of a dynamic, international team and grow with us? Then apply now as :

Senior Director Regulatory Global Specialty / Biosimilar Development (f / m / d)

Bad Vilbel | Germany (DE) | Full-time | Permanent | Portfolio & Product Development | Professionals

What you can expect

  • You define clear roles and responsibilities for individual team members
  • You define and prioritize individual deliverables across the department, closely aligned with overarching department objectives
  • You develop individuals and assure the overall team performance
  • You are responsible for the definition of relevant KPIs for Regulatory department to assure consistent performance tracking
  • You have the oversight of all regulatory activities incl. Contribution to due diligences if applicable and preparation of regulatory interactions and assurance of delivery of all regulatory documents
  • You close monitoring of new regulatory trends, guidance and guidelines and translation into potential impact assessment on STADA Specialty and Biosimilar business
  • You take care of the development and implementation on state-of-the art processes
  • You are responsible for the identification and implementation of best-in-class tools to support the department and the team
  • You are the go-to expert for all kind of global & local Regulatory questions Deputy
  • You are the Deputy of Head Global Specialty Development

Who we are looking for

  • You have a Master in Life Science, Ph.D.
  • You have 15+ years of experience in Pharmaceutical industry and 8 + years of experience in Regulatory affairs incl. global positions
  • You have a 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
  • You have a broad coverage of regulatory topics from CMC, Clinical, Devices, labelling, pre-approval inspections, etc.
  • You have a proven track record as team leader either in line or matrix setting
  • You bring a Robust understanding of Biologics / recombinant molecules, ideally also Biosimilars with you
  • You are an experienced user of regulatory intelligence software, publishing tools and document management software (preparation of eCTDs)
  • You are a strong communicator, both verbally and in writing
  • You are a team player, proven to be successfully working in global and cross-functional environments
  • Your focus is entrepreneur with proactive and agile working style – resilient in facing ambiguity at the same time efficiently deploying project management skills
  • You are open-minded and curious to explore new ways of working
  • You have excellent knowledge in English, any other language(s) as German are a plus

    • What we offer

  • An open corporate culture with fast decision-making processes and a lot of potential for your personal development
  • Individual development and training opportunities
  • Flexible working hours and mobile working up to 2 days per week (depending on the job profile)
  • Job ticket for the RMV region and Job Bike
  • Childcare allowance
  • Health-promoting offers such as or the STADA Gym (free of charge)
  • Numerous additional benefits such as group accident insurance or supplementary pension scheme
  • Subsidized cafeteria

    • We look forward to receiving your application via our . At jobs.stada.com you will also find numerous other job opportunities, as we are always looking for motivated talents who can strengthen our team with their expertise and personality. Do you have further questions? Then please reach out to . We will consider requests to work part-time on an individual basis. Please contact us in advance by e-mail (.) and let us know how many hours per week you would like to work.

    STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology or sexual orientation. We use the strength of this diversity to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment. #LI-NS1 #LI-HYBRID