Regulatory Project Manager
We are looking for a highly motivated Regulatory Project Manager to join a prestigious pharmaceutical company in Romania. This is an amazing opportunity to bring your experience and knowledge to a company that effectively contributes to medicine.
- Support Renewals planning, tracking and requirements / packages preparation for submission to HA,
- Manage the follow ups with local RA contacts at clients affiliates, for transitional processes for ongoing RA activities
- Monitoring the quality safety variations compliance and tracking databases updates,
- Monitor transitional processes for client RA databases maintenance
- Support GRA Quality initiatives (PSMF ex BI, …),
- Participate to switch of RA responsibility and accountability within integration projects (R-TSA exit preparation, ..)
- Implementation of remediation actions following non-compliance cases,
- Participate to source documents migration from to Sanofi storing databases,
- Support the team in any day to day activities (Project management, slides preparation, meetings facilitation, Microsoft package fluency…), as relevant.
- Participation and support to any HA inspection / Internal and external audits,
Skills and Requirements
- Bachelor's degree is required.
- Experience, knowledge, and skills should include 3-5+ years' experience in one of the two following areas:
- Experience in a biotech, pharmaceutical, medicine, CRO, or related life science organization. Candidates with Project Management background in these industries preferred, OR
- Experience planning, managing/leading, and delivering technical or complex projects that are service-based and client facing.
- Excellent communication skills - verbally, in writing, and via presentations.
In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at 0207 440 0679 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.