Global Head of Labelling - Frankfurt am Main, Deutschland - Haybury

Haybury
Haybury
Geprüftes Unternehmen
Frankfurt am Main, Deutschland

vor 3 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung
A fantastic new opportunity has been created for a leading, global pharmaceutical company, based in their global headquarters.

My client is a market leader, at the frontier of drug research and development, with promising first-in-class and potential medical breakthrough pipeline projects.


The Head of the Global Labelling within the Global Regulatory Affairs (GRA) department has different responsibilities in the area of drug development, drug law compliance, management, and training.


Responsibilities:


  • Key member of the Global Regulatory Affairs Leadership team, contributing to the overall department strategy
  • Develop and maintain the Company Core Data Sheet (CCDS) for medicinal products as well as Company Core Instructions for Use (CCIFU) for medical devices
  • Work in cooperation with Chief Medical Officer, Head of Patient Safety and Pharmacovigilance, Head of GRA
  • Lead strategic oversight and management of the Global Labeling processes
  • Provide quality and compliance oversight for the labeling process in line with regulatory and GxP requirements
  • Lead pharmacist trainees with focus on CMC, preclinical, clinical drug development and drug law / regulatory aspects

Job requirements:


  • Graduate degree (e.g., M.Sc., Ph.
D., M.D.) in statistics, health economics, medicine, pharmacy, life Doctoral Degree (e.g. PhD, MD) and/or Master's Degree in pharmacy or life sciences or certified Pharmacist

  • Longstanding leadership experience required; by leading employees, projects or functions
  • Indepth global knowledge in RA, PV and Medicine
  • Strong medical, pharmaceutical, and scientific knowledge, and a broad understanding of different therapeutic areas
  • Excellent knowledge of current legislation, in particular with regard to labeling and compliance
  • Proven international business experience
  • Critical thinker with ability to selfmanage workload, including reprioritizing and delivery under tight timelines
  • Sound decisionmaking, negotiation, and problemsolving skills in an independent manner
  • Strong interpersonal skills, as well as the ability to build relationships and work in a team environment
  • Fluent English language skills, both written and spoken

In return you will receive:


  • The opportunity to work within a truly innovative, global pharmaceutical organisation with substantial exposure to senior leadership and opportunities to advance your professional growth
  • The chance to shape clinical trials for an upcoming product with huge potential
  • Competitive remuneration package with lucrative bonus scheme
  • Excellent career development opportunity
  • By phone:

Job Types:
Full-time, Permanent


Work Location:
One location
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