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Associate I Regulatory Submissions * REMOTE *

Company: Labcorp Drug Development, Labcorp
Location: Burlington
Posted on: September 19, 2022

Job Description:

If you are looking to work for a top rated CRO with flexibility to work from home, LabCorp Drug Development wants you! Our ideal Associate I Regulatory candidate has knowledge of the five modules relating to eCTD, experience with IND submissions, is comfortable working with health authorities (FDA / Health Canada) and is looking to grow with our organization in the long-term under supportive leadership.Preferred experience is focused in GCP What to Expect

  • 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 projectsPlease note that this is not a Regulatory Operations Publishing role. Education / Qualifications
    • Bachelors Degree in Life Sciences or equivalent
    • Excellent communication skills, organization and planning skills and attention to detailExperience
      • 1+ years experience industry (pharma, CRO)
      • Experience in the pharmaceutical / CRO industry preferredLabcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.For more information about how we collect and store your personal data, please see our

Keywords: Labcorp Drug Development, Labcorp, Burlington , Associate I Regulatory Submissions * REMOTE *, Other , Burlington, North Carolina

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