​Charterhouse is presently managing a search, for Regulatory Affairs Specialist.
About the role
This role will be responsible in coordinating and managing data collection, reporting dissemination and following up of any events within deadline.
In addition, you will also identify root causes of deviations or ingredients along with the management team, escalating risks and variances when appropriate.
You will be involved in resource tracking and forecasting, reporting process for compliance with timelines for delivery of labelling updates with global, regional, and local partners, in accordance with the company’s policies and procedures.
In conjunction, you will participate in other projects and activities that support other labelling functions, such as contributing to the implementation of changes to processes within Global Regulatory Affairs.
About you
Our client is looking for a Qualified Regulatory Affairs Specialist who has at least 5+ years post qualification experience with a Bachelor Degree in Pharmacology, Chemistry, Biology or Medicine.
To be considered for this role, the candidate shall be able to present relevant experience with Labelling systems, standard operating procedures, and legislative requirements, entry, tracking and registration data management systems, regulatory document management, including experience with Documentum databases and MS team sites.
Additionally, you are required to carefully work under time constraints and prioritize accordingly.
You must be adaptable to fast-paced environments with changing circumstances, direction, and strategy and must have exposure to work within a regulated environment, in drug, medical devices and cosmetic development.
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