(Sr) Regulatory Affairs Consultant CTA/IND - client dedicated (Flexible location UK/EU)

We are looking for Regulatory Affairs Professionals CTA/INDon various levels (Consultant, Senior Consultant, Principal Consultant) for a client dedicated project within Parexel FSP Group.

The role can be home or office based in various European locations.

As the Regulatory Affairs CTA/IND Specialist you will 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 related to DSUR process with the different stakeholders (eg: NSC – LOC’s)

You will also ensure the following project management for CTA by:

Defining the CTA/IND strategy within R&D and managing the planning, coordination and/or preparation, dispatch and follow-up on the initial clinical trial/IND application file, Q&A’s, amendments , end of trial notification and summary of clinical trial report (including DSUR’s)  in order to ensure a timely submission to appropriate authorities such as Competent Authorities (CA – such as Ministry of Health)

Flagging operational issues and proposing solutions in a timely manner

Supporting the LOCs for their submission to their authority and ethics committees by providing help and guideline on procedural and administrative matters

Skills and Experience required for the role:

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)

Good organizational, interpersonal and communication skills

Flexibility and proactive thinking to meet business requests

Rigor, quality mindset

Team player

Demonstrated skills for training and presentation

Fluency in spoken & written English. Knowledge in French or Italian is a plus.