Location: Maidenhead, UK
Closing Date: 13 Feb 17
Salary (£): Competitive
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
We are currently recruiting for a Regulatory Submission Associate to join Covance Team in Maidenhead.
You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
About the job:
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 in the preparation of submissions filed to Regulatory Authorities (e.g.: INDs, CTAs, NDAs, NDSs, MAAs or CTDs).
♦ Contribute to the preparation of submissions to Regulatory Authorities by reviewing/summarizing scientific/research documents.
♦ Assist in the coordination, collection and organization of information required by Regulatory Authorities.
♦ Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.
♦ Maintain knowledge and awareness of regulations and guidelines pertaining to drugs and biologics.
♦ Monitor compliance with regulatory requirements in relation to assigned projects.
THERE IS NO BETTER TIME TO JOIN US!
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