Ra Consultant Cta/Ind Remote Any Seniority Level Lazio

Ra Consultant Cta/Ind Remote Any Seniority Level
Roma
Lazio, Lazio

The world's leading global CRO has several open positions for Regulatory Affairs Professionals CTA/IND for a client-dedicated project and thus can be suitable for Consultants, Senior Consultants as well as Principal Consultants.

In this role, the specialist is expected to provide technical/coordination support and expertise within the client's vaccines group in particular for the R&D, Global Quality Vaccines & Legal/Patent departments and outside of the group (eg:

EMA) to ensure:

The appropriate project management related to CTA/IND process with the different stakeholders by issuing the master planning/strategy to ensure timely due submissions and approvals of CTA's/IND in compliance with ethical and regulatory standards The upload and maintenance of the third country form (related to articles 41 & 46) via the EMA gateway The appropriate project management associated with DSUR process with the different stakeholders (eg:

NSC - LOC's) You will also ensure the following project management for CTA by:

A background in clinical trial management Good expertise in CTA and associated regulations Ability to coordinate projects also with external partners Good prioritization skills in function of business impact and criticality (project management) Flexibility and proactive thinking to meet business requests Demonstrated skills for training and presentation Fluency in spoken & written English.

Knowledge in French or Italian is a plus.

Bonus:

you can work from home or in one of the offices in the EU or the UK.

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