Senior Regulatory Affairs Associate (Global RA Manager)

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 clients' quality expectations.

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

Key Responsibilities: Preparation, coordination, and submission of registration dossiers to health authorities Elaboration of the regulatory submission strategy (US FDA, EMA Article 58, WHO prequalification, Local registrations) Preparation and submission of the responses to health authorities questions Regulatory project management (development and life cycle management) Preparation and submission of variation dossiers (labeling) Preparation and participation to WHO GMP inspections Marketing authorization renewals follow-up, regulatory support on tenders, artwork reviews QualificationsBA/BS in scientific or technical discipline or advanced degree At least 3 years of CMC/regulatory affairs experience Thorough understanding of regulatory requirements Strong problem solving and diplomacy skills Excellent project management skills Fluent English