Beschreibung
Requirements:- Professional experience in Regulatory Affairs in R&D environment min 6 years
- Strong hands-on practise from recent CP & DCP
- Profound knowledge of dossier requirements (NtA, ICH, CTD, CHMP, EMEA guidances) and Regulatory Procedural Management (agency contacts, internal review processes)
- Hands-on experince with preparation and attendence of presubmission and Scientific Advice Meetings
- Experienced in preparation of "regulatory" documents as application forms, SmPC and PIL, etc
- very good computer and MS office skills, internet researches
- very good English and communication skills
- German
Details:
Volume: ~ 30 hours / week (negotiable)
Duration: 3 -6 months
Location: on-site (North Germany) & remote
Start: ASAP
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