Job Overview :
Labcorp are recruiting an Associate II Regulatory Submissions to join our team in Poland.
Job Summary :
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 Labcorp 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 (Annex I, II & III) and cover letter.
Assist in the preparation of routine submissions filed to Regulatory Authorities (e.g. INDs / CTAs and NDAs / MAAs / CTDs).
May take ownership of specific pieces of work.
Assist in the coordination, collection and organization of data and information required by Regulatory Authorities.
Assist in client meetings and proactively liaise with clients on Regulatory Submission issues.
Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.
Maintain knowledge and awareness of regulation and guidelines 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
Candidates should ideally have at least 2 years experience performing submissions to Regulatory Authorities.
Must be able to communicate effectively in the English Language.