Global Regulatory Affairs Project Manager (m/f)

Hesse  ‐ Onsite
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Keywords

Description


We are looking for a
Global Regulatory Affairs Project Manager (m/f)

Reference: -en
Start: asap
Duration: 12 MM
Place: in Hesse
Branch: Wettbewerber

Your tasks:
  • Manage the regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentation at different Regulatory milestones
  • Management of the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes (under supervision of a TA Head or Regulatory Strategist)
  • Participate in regulatory strategies for projects (under supervision of the Regulatory Strategist )
  • Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labelling) including CTAs


Your qualifications
  • Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
  • Excellent spoken and written English
  • Experience in Pharmaceutical industry and also Regulatory Affairs
  • Experience in preparation and submission of a full submission or large variation/supplement in at least one ICH region through to authorization



Skills:
- Regulatory affairs manager


Keywords: Regulatory Affairs Manager
Start date
ASAP
Duration
12 MM
From
Hays AG
Published at
17.11.2014
Contact person:
Kerstin Werner
Project ID:
809218
Contract type
Freelance
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