Regulatory Affairs Associate (Global RA Manager-Labeling)

A fantastic opportunity has arisen within Parexel Romania to join in a client-dedicated role as a Regulatory Affairs Associate.

A 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 provides. A Regulatory Affairs Associate must have good technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Regulatory Affairs Associate ensures the timely performance of work within a project scope to the quality expectations of PC and the client.

We are currently looking for a Regulatory Affairs Associate with the following responsibilities:

Key Responsibilities: Regulatory submissions (update of existing MA) Maintenance and coordination of regulatory activities in subsidiaries (responses to Health Authorities, questions regarding the local implementation of global labeling documents) Provide support to multidisciplinary labeling working group (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs) for labeling proposals, preparation of supportive documents and dossiers for labeling modifications QualificationsBA/BS in scientific or technical discipline or advanced degree 2- 3 years of labeling/regulatory affairs experience Understanding of change management processes and regulatory requirements Strong problem solving and diplomacy skills Excellent project management skills Fluent English