Freelance Consultant Regulatory Affairs EU Strategy (m/w/d)
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Vienna, Austria | 
Freelance
Job title: Freelance Consultant Regulatory Affairs EU Strategy (m/w/d)
Industry: PharmaSkills: Regulatory Affairs, Regulatory Strategy, EMA
Start of project: 01.06.2023
Duration of the project : 12 months
Project volume: 240 hours
Location: Vienna, Austria
Tasks:
- Independent review of EU Regulatory Strategy documents
- Consulting regarding relevant standards for the submission of documents to the European authorities
- Advisory on suitable strategies for submission to the European authorities (central and national)
- Consulting on specific questions of the department regarding current regulatory topics
- External perspective on internal regulatory processes including proactive feedback
Qualifications:
- Over 10 years of experience in pharmaceutical regulatory affairs (SMEs or bigger corporations)
- Extensive knowledge of the guidelines for new products, indications and product updates of the EMA as well as the Paul-Ehrlich-Institute
- Good knowledge in the field of biologics
- Understanding of clinical trials and protocols
- English fluency is a must
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Kontakt
Dominic Blümelhuber
12935
Pharma
01.06.2023
12 Monate
Freelance
