FSP Regulatory Affairs - EEA Regulatory Leader

We are looking for Regulatory Affairs professionals on various level to join us as a Regulatory Affairs Leader for EEA countries. This is a client dedicated role within our Functional Service Provider model. The role can be based in multiple locations in UK and EU (home or office based).

Role responsibilities:

• Create EAA submission strategy per application type (incl. analysis of impact on Part I / II and alignment with stakeholders)

• Prepare Part I Dossier outside of CTIS via e-system Vault Clinical (incl. consolidated cover letter, table of content, structured data template), QC content before Sponsor review via Vault

• Ensure availability of Part I document redacted versions and translations

• Oversee application RFI response management

• Prepare/manage response to Part I RFI considerations

• Prepare/manage ad-hoc RFI responses

• Prepare/manage trial/recruitment-level and circumstantial event notifications for EEA

• Collaborate with SSU Lead / COL who oversees Part II readiness incl. response to Part II RFIs

• Communicate to Sponsor and cc Global Reg Leader (if GRL is different from EAA-CTR Reg Lead)

• Provide timely project updates to Sponsor and internal team

• Ensure regular communication is provided to Sponsor, Project Lead, Start-up / Clinical Operations Lead, CTIS Central team and other team members

Skills and Experience:

University degree (preferably biological/chemical)

3 + years of RA submissions experience

Knowledge of Regulatory legislation in EEA counties

Analytical capacity and good organizational skills

Good communication, negotiation skills and presentation skills

Project management skills

Fluent in English written and spoken

#LI-REMOTE