Pharma Biberach: Submission Manager (m/w/d)

Für unseren renommierten Kunden aus der Pharmaindustrie in Biberach suchen wir ab sofort :

Pharma Biberach: Submission Manager (m/w/d)

Ihre Aufgaben

  • The Submission Manager is responsible for aspects of global administration databases and processes
  • Works closely with Senior Submission Manager on submission management and delivery to internal stakeholders globally and ensure all submissions are technically valid and complete.
  • Responsible for aspects of publishing outsourcing and has a  broad variety of internal and external international interfaces related to GRA, GPV, LRA, and our vendor to ensure timelines are met  globally to avoid delays to a Health Authority
  • The Submission Manager has interface with other teams in Publishing Operations to ensure processes are efficient and without impact to global submission timelines

Ihre Qualifikationen

  • Structured and self-organized working style
  • good understanding of the interfaces to other departments and partners internally and externally in order to collaborate effectively and, at times, under pressure and tight timelines
  • Good coordination and communication skills
  • Business fluent English
  • Profound experience in dossier publishing and advanced knowledge in dossier standards and international regulatory authorization processes/procedures
  • good understanding of global submission requirements and technical specifications worldwide
  • Confident in using BI applications and software for document, publishing and viewing
  • good understanding of document management tools, as well as publishing systems
  • responsible for timely and high-quality work in relation to global submissions and reporting

A Bachelors degree (e.g., life sciences, computer science, informational technology or equivalent) is required or equivalent on-the-job experience, plus minimum of 3 years of Regulatory Affairs experience in the pharmaceutical industry


Wir freuen uns auf Ihre Bewerbung und auf eine gute, vertrauensvolle und erfolgreiche Zusammenarbeit!

Gewünschte Bewerbungsarten

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  • schriftlich
  • telefonisch
  • persönlich

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Frau Poser

Telefonnummer: +49 (73 51) 82 98 63 20

apero GmbH
Marktplatz 1
88400 Biberach an der Riß