Senior Regulatory Affairs Associate (Clinical writer)

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 quality expectations.

We are currently looking for a Regulatory Affairs Consultant who will have the following responsibilities: Regulatory Delivery Experience in LCM (Clinical and Labelling) Strong understanding of regulatory labelling (and clinical) lifecycle maintenance activities across EU and ROW markets Change Control assessment experience or transferrable skills (application of relevant regulatory guidance to proposed change) Needs experience in: PSUR updates, management of CCDS updates and submission experience of simple and complex labelling variations to EU markets Capable of participating in discussion on regulatory strategies with a wide stakeholder network (Global Labelling, Supply, Brand Leads etc.) with support of an SME ‘Proactive’ and ‘efficient working method Able to adhere to internal and HA timelines QualificationsIdeal candidate will possess: Good understanding of performing the above regulatory tasks on a global level Several years of MAA and Lifecycle Maintenance experience for EU and APAC/LATAM Change control assessment experience for EU Very good project management skills Proactive approach and excellent communication skills Fluent English University degree

2021-12-01 00:05:20

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