Analyst Iii Regulatory Publishing

Year    Hyderabad, Telangana, India
DXC Technology
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Job Description

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  • Successfully meet/ complete training milestones relevant to the position held.
  • Familiarity with FDA, GCPs, ICH guidelines, Life Sciences & Pharmaceutical industry
  • Familiarity of health authority procedures / guidance regarding electronic submissions
  • Perform submission publishing, assembly, and distribution activities within the specified training period
  • Notifying relevant stakeholders that the file is ready for approval
  • Multi-skilled on all allocated submissions within the team
  • Adapting and willing to multi-skill and assisting in other submission/task within the team
  • A high level of independent judgment/action in problem solving
  • Keeping Team Leader informed of non-routine issues, making recommendations to resolve these issues
  • Self-Development and Take Responsibilities for the same
  • Active involvement in projects and quality/change initiatives
  • By continually upgrading domain knowledge
  • Following company rules and standard operating procedures
  • Adhering to all Security Policies and Procedures
  • Promoting a positive and professional image of the team always
  • Need to abide to the existing Information Security Policies and Procedures
  • Bachelors degree in life sciences specialty (pharmaceutical /biotech) 1-2 years of Regulatory Publishing experience
  • Familiarity with FDA and ICH guidelines, Life Sciences & Pharmaceutical industry
  • Experience with various document types (CSR, CMC, Nonclinical, CRF) and applications (IND, NDA, ANDA)
  • Familiarity of health authority procedures / guidance regarding electronic submissions.
  • Some global application experience (US, EU, etc.)
  • Minimal supervision required for common publishing tasks
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Job Detail

  • Job Id
    JD3331485
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Hyderabad, Telangana, India
  • Education
    Not mentioned
  • Experience
    Year
 
 
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