Senior Regulatory Affairs Consultant (Regulatory Compliance)

We are currently looking for a Regulatory Affairs Senior Consultant with Regulatory Compliance experience to join our Regulatory Consulting team in Romania.

A Regulatory Affairs Sr. Consultant at Parexel 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 Sr. Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Regulatory Affairs Sr. 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 Sr. Consultant assures the work of the entire team is delivered on time and that it meets client’s and PC’s quality expectations.

Regulatory Affairs Senior Consultant (Regulatory Compliance) will have the following responsibilities: Perform a gap analysis on the current client's EU regulatory processes (this can also include systems). Suggest process improvements. Be responsible for driving through the changes as identified in the gap analysis. Act as Regulatory CMC Product Lead QualificationsThe ideal candidate will possess: BA/BS in a scientific or technical discipline or advanced degree Extensive Compliance / QA expertise Understanding of regulatory process requirements. Ability to perform an audit of existing systems/processes and identify gaps. Drive the plan for improvements. EU regulatory knowledge as a potential to act as regulatory CMC product lead Project management skills Fluent written and spoken English