Job Overview :
Covance is looking to recruit Regulatory Specialist to join our team in Ukraine - full time, permannet role.
This person will Responsible for providing support to regulatory managers and others for the timely submission of information to Regulatory Authorities in support of investigational and marketed products.
Interacts with Regulatory Authorities and with clients to support regulatory activities. Proactively
interacts with other Covance groups and with clients to provide guidance regarding Regulatory
Authority requirements and project timelines and requirements. It is the responsibility of the
Regulatory Associate to prepare documents to the required standard and to maintain awareness of current regulatory standards related to submissions for drug and biologic products.
Essential Job Duties :
Assist with the preparation of study documentation such as the core EudraCT Form and cover letter.
Assist in the preparation of routine submissions filed to Regulatory Authorities
Assist in the coordination, collection and organization of data and information required by
Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.
Maintain an awareness of regulatory legislation, guidance and practice pertaining to drugs and biologics.
Monitor compliance with regulatory requirements in relation to assigned projects.
Work on special regulatory projects as assigned
Education / Qualifications :
Bachelor's Degree in Life Sciences or equivalent
minimum 1 year experience in the Pharmaceutical industry, preferably in Regulatory Affairs or Drug Development