Category

Description

Senior Regulatory Affairs Specialist

Your Job:

As a part of our "Regulatory Affairs" team, your duties will primarly include the support to management of assigned clients and projects. You will operate within local and multinational Regulatory Affairs teams, collaborating with colleagues and clients. This includes the following duties:
Participation in regulatory processes to gain and maintain European marketing authorizations
Support in preparation of documents within the framework of regulatory affairs projects (procedures, renewals, variations) in agreement with projects leads
Support in project work (e.g. compilation, preparation and reviewing of documents)
In agreement with Line Manager provide on-site regulatory support to PharmaLex clients
Communication with the client and the Health Authorities in agreement with Line Manager

Your Profile

University degree in pharmacy or other natural sciences
3 - 5 years of professional experience
Content-related experience in Regulatory Affairs
Fluency in spoken and written English
Strong service orientation
Good communication skills
Independent approach to work, flexibility and dedication
Ability to prioritize parallel tasks, escalate issues where appropriate and offer solutions for appropriate counter measures
Attention to detail
Strong sense of responsibility and pronounced motivation

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