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Regulatory Affairs Associate (On site) - Parexel

Date Posted: Apr 18, 2024
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Job Detail

  • Location:
    Hyderabad, Telangana, India
  • Company:
    Parexel
  • Type:
    Full Time/Permanent
  • Shift:
    No
  • Career Level:
    No
  • Positions:
    No
  • Experience:
    No
  • Gender:
    No Preference
  • Degree:
    No
  • Apply Before:
    May 18, 2024
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Job Description

Regulatory Affairs Associate
2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.
  • To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
  • To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including:
o Submission delivery strategy
o Review of documents
o Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
  • Liaise closely with cross-functional members with aligned product responsibilities.
  • Develop, execute, and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
  • Authoring the dossier sections based on the changes to approved MAA
  • Knowledge of change evaluation according to country guidelines
  • Experience in managing lifecycle activities in the EU markets would be preferrable
  • Knowledge of CTD guidelines
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Skills Required

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Company Overview

Parexel
, India
0 Current Jobs Openings

Parexel strives to be the premier provider to the biopharmaceutical and medical device industries for the development and commercialization of new medical therapies worldwide. Headquartered near Boston, Massachusetts, Parexel operates in 82 location... Read More

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