Senior Regulatory Affairs Manager

Project-ID: 1328

Ihr Aufgabengebiet

  • Management and supervision of  Regulatory Operations systems (e.g. Veeva)
  • Working with several departments (e.g. Clinical and CMC Regulatory Affairs) and cross-functional teams
  • Plan and taking care of the timely submission of all regulatory applications to international health authorities (e.g. IND, NDA, MAA)
  • Track regulatory submissions within RIM system (incl. publishing of electronic regulatory applications, mainly in the eCTD format)
  • Serve as the primary point of contact for regulatory publishing activities
  • Responsibility for the formatting and completeness of the documents
  • Preparation of guidance of regulations for publication in the eCTD Formatting of applications, contact person for problems related to publication
  • Identify potential risks to submission plans and create mitigation strategies
  • Monitoring global and national regulations and guidelines and adapting submission specifications (focus on FDA, EMA, Health Canada, and ICH)
  • Responsible for the regulatory operations tools (e.g. SharePoint) and for the publication of documents
  • Promote the ongoing set-up of a new RIM system (including system configuration, data migration, etc.)
  • Archiving of health authority communication
  • Follow-up of questions and commitments
  • Taking over the task as RIM administrator incl. training of tool users
  • Develop internal process documentation, including SOPs, work instructions
  • Report to Regulatory Leads

Ihr Hintergrund

  • Completion of a science degree (“nice to have”: additional training in drug regulatory affairs
  • Very good experience within the field of regulatory (publishing and submissions in the eCTD format)
  • Knowledge of Veeva Vault (must have)
  • Advanced knowledge of regulations and guidelines (EMA, FDA, and ICH)
  • Very good German (not mandatory) and English skills
Gender-Hinweis

Aus Gründen der besseren Lesbarkeit wird auf die gleichzeitige Verwendung der Sprachformen männlich, weiblich und divers (m/w/d) verzichtet. Sämtliche Personenbezeichnungen gelten gleichermaßen für alle Geschlechter.

Vertragsart

Festanstellung

Branche

Pharmaceuticals

Fachbereich

Regulatory Affairs

Ort

Remote

Deutschland

Starttermin

ASAP

Dauer

Unbefristet

Remote

ja

Auslastung (FTE)

1

Ihr Ansprechpartner
KGU_neu
Karoline Gutensohn

Senior Recruitment Managerin

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