Covance

  • Associate II, Regulatory Submissions, Sofia

    Job Location(s) BG-Sofia
    Job Number
    2018-19596
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    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.

     

    Responsibilities:

    • 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

    Experience

    • 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.

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