Senior Manager Regulatory Affairs (gn)

München  ‐ Vor Ort
Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
Sie finden vakante Projekte hier in unserer Projektbörse.

Schlagworte

Regulatory Affairs Klinische Forschung Marketing Naturwissenschaft

Beschreibung

Sie bringen min. 5 Jahre Erfahrungen im Bereich Regulatory Affairs mit und suchen dem Sprung zu einem namhaften Biotech-Unternehmen in München? Dann dürfte folgende Stelle bestimmt sehr interessant für Sie sein:

Senior Manager REGULATORY AFFAIRS

With considerable independence, lead regulatory activities for assigned products and topics
  • Manage all activities needed to ensure compliant labeling for medicinal products in the country (SmPC, PIL, packaging) and manage timely updates for assigned product(s)
  • Handles Translation Review of German Annexes associated with variations related to centrally approved Marketing Authorizations (MAs)
  • Responsible for review and approval of promotional material for the assigned medicinal products
  • Management of quality defects, falsified or counterfeit products for assigned products
  • Manages or contributes to regulatory submissions to local Health Authority (HA)
  • Support to ensure compliance with relevant national legislation and regulation and consistency with global procedural documents
  • Monitor competitor regulatory information such as approvals, changes in label and other relevant local details
  • Provides regulatory strategic input to local brand teams and other internal working parties
  • Play an active role in ad hoc special projects that continuously improve or otherwise advance Regulatory Affairs capabilities impacting the working of the Regulatory Affairs functions


Knowledge, Experience & Skills
  • University degree or comparable education preferably in Natural Sciences, Medical Sciences or Pharmacy
  • Significant experience (6+ years) in Affiliate RA role and regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements and regional requirements
  • Knowledge of Medicinal Products Act in general and further legislation (AMG, AMWHV, HWG, GCP-Regulation, Clinical Trial Directive & CT Regulation etc), GDP, GMP
  • Teamwork, analytical thinking, organization skills and ability to work on a number of projects with tight timelines is required
  • Excellent verbal and written communication skills (German and English) organization skills and interpersonal communication skills required


Haben Sie Interesse an dieser Stelle? Dann freue ich mich über Ihre Bewerbung!

Herzliche Grüße aus München,

Stefan Blöchl
Start
06/2024
Dauer
18
Von
Progressive IT
Eingestellt
17.05.2024
Projekt-ID:
2752205
Vertragsart
Festanstellung
Um sich auf dieses Projekt zu bewerben müssen Sie sich einloggen.
Registrieren