Interim Labeling Manager (f/m)

Arbeitsort Rhein-Main-Gebiet
Berufsgruppe Life Sciences (Natur­wissen­schaften)
Arbeitszeit Vollzeit
Branche Chemie/Pharma/Kosmetik/Kunststoff
Veröffentlicht am 20.07.2016
Jetzt bewerben

adesta - success is our attitude

adesta sees itself as a partner for customers as well as for employees and applicants. Each appreciate the high-quality, individual advice and support which they receive at adesta.

On behalf of our client, a world-renowned pharmaceutical enterprise with headquarters in the Rhine Main area, we are looking for an

Interim Labeling Manager (f/m)

  • Creates and maintain Global Regulatory Product Information (Reference Product Information, RPI) documents as the basis for worldwide harmonized Labeling
  • Leads all labeling-related activities within the cross functional product teams (e.g. Regulatory Sub-Team, Labeling Team, Global Project Team) for assigned products
  • Ensures consistency between the RPI and national labeling documents and provide labeling related advise to the cross functional experts and to countries
  • Coordinates and prepares response to labeling-related questions from authorities (content and format)
  • Oversees creation and maintenance of minimum text requirements for global Master Packaging as the basis for worldwide harmonized packaging material
  • Analyses competitor labeling
  • Be aware of local and regional labeling requirements, particularly EU
  • Provides revised SmPC, labelling and PL texts in English for EU procedures ( CP, MRP, DCP)
  • Coordinate translations for CPs
  • Have a solid knowledge on Pharmacovigilance requirements
  • Working place: 80% on site, 20% remote
  • Pharmacist, chemist, biologist or similar background
  • At least 5 years regulatory and labeling experience in Pharma Industry
  • Solid problem solving skills
  • Excellent communication skills
  • Fluency in English (oral and written)
Are you interested in this challenging freelance job? Then please submit your profile (in English) under specification of reference number 29-302-244. If you have any questions, please do not hesitate to contact Mr. Jungclaus.

„Insbesondere hat mich die respektvolle und freundliche Art und Weise beeindruckt. Jede meiner Fragen wurde rasch beantwortet, jedes Anliegen sofort erledigt. Ich fühlte mich sehr wohl als Mit­ar­bei­terin der Firma adesta, die Betreuung war einwandfrei, kompetent und die Kommunikation war immer auf Augenhöhe.“

Susanne Fendrich