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: Pharma

Skills: 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