Regulatory Affairs Consultant (France MAA experience)
Parexel International Corporation
Bucharest, București, Romania
A Regulatory Affairs Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel Consulting provides. A Regulatory Affairs Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Regulatory Affairs Consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Technical Lead, a Regulatory Affairs Consultant assures the work of the entire team is delivered on time and that it meets client’s and PC’s quality expectations.
We are currently looking for a French speaking Regulatory Affairs Consultant for (office or home based in Romania) who will have the following responsibilities: Good understanding of MAA and lifecycle maintenance activities in FRANCE Change Control assessment experience (application of relevant regulatory guidance to proposed change) Submission experience of Simple (Type I) and complex variations (Type II) to FRANCE in the CP, MRP and NP procedures. Experience in reviewing promotional materials. Capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME. Proactive and efficient working method. Strict adherence to timelines (both internal and HA deadlines). QualificationsIdeal candidate will possess:
Fluent French and good English University degree, life science degree preferred Good understanding of performing the above regulatory tasks on a global level Several years of MAA and Lifecycle Maintenance experience for FRANCE Change control assessment experience for EU Very good project management skills Proactive approach and excellent communication skills