Senior Regulatory Affairs Associate (Dossier Manager)

We have a new, compelling opportunity to join a client-dedicated project as a Senior Regulatory Affairs Associate (Dorrier Management) in Romania.

A Regulatory Affairs Sr.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 Sr.Associate must have good technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Regulatory Affairs Sr.Associate ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Lead, a Regulatory Affairs Sr.Associate assures the work of the entire team is delivered on time and that it meets the client’s quality expectations.

We are currently looking for a Regulatory Affairs Sr.Associate who will have the following responsibilities:

Key Responsibilities: Preparation & submissions of regulatory files Communicate with Regulatory Operations on the planning of marketing applications and post-approval supplements and variations Coordinate the review and approval of submission-ready documents Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations QualificationsBA/BS in scientific or technical discipline or advanced degree At least 3 years of regulatory affairs experience performing the same activities at global level Thorough understanding of regulatory requirements Strong problem solving and diplomacy skills Excellent project management skills Fluent English