Covance Associate II, Regulatory Submissions, Sofia in Sofia, Bulgaria
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.
Assist in the preparation of routine submissions filed to Regulatory Authorities (e.g.: INDs, CTAs, NDAs, NDSs, MAAs or CTDs). May take ownership of specific pieces of work
Contribute to the preparation of submissions to Health Authorities by reviewing/summarizing scientific/research documents
Assist in the coordination, collection and organization of 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 regulations and guidelines pertaining to drugs and biologics
Monitor compliance with regulatory requirements in relation to assigned projects
Education / Qualifications
Bachelor’s Degree in Life Sciences or equivalent
Excellent communication skills, organization and planning skills and attention to detail
Proven experience in the pharmaceutical industry, preferably in drug development or regulatory affairs
Core and Leadership competencies: Focus on Customers, Innovate and Change, Pursue Scientific and Process Excellence, Work with Others, Achieve Results.
Job Number 2018-19596
Job Category Clinical Operations
Position Type Full-Time
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