Labcorp Drug Development are recruiting for an Associate I, Regulatory Submissions to join our team in Madrid.

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 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 (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).

¨ Assist in the coordination, collection and organization of data and information required by Regulatory Authorities.

¨ 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.

#LI-NC1 REMOTE
Education/Qualifications:
Recommended: Bachelor's Degree in Life Sciences or equivalent.
Experience:
Minimum Required: At least 1 year Regulatory Submissions experience.