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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

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