- Clinical research jobs
- Senior Regulatory Affairs Associate (Publishing)
Use our `search` to find similar offers.
Senior Regulatory Affairs Associate (Publishing)
Parexel International Corporation
Bucharest, București, Romania
A Senior Regulatory Affairs Associate must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel Consulting (PC) provides. A Senior Regulatory Affairs Associate must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Senior Regulatory Affairs Associate ensures the timely performance of work within a project scope to the quality expectations of PC and the client. A Senior Regulatory Affairs Associate 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 Senior Regulatory Affairs Associate who will have the following responsibilities: Management of predominantly EU regulatory operations publishing work – including: - Mailbox & tracker management
- Schedule & timelines management between client and Parexel teams
- Final 20% QC of published dossiers
- Dispatch via CESP/agency portals
- Archival via client RIM system QualificationsIdeal candidate will possess: Good understanding of performing the above regulatory tasks on a global level University degree in life sciences Regulatory Operations/Publishing experience Fluent English and Romanian Good project Management skills Proactive approach and excellent communication skills
Job posted: 2021-07-07