Analyst Iii Regulatory Publishing

Year    Hyderabad, Telangana, India
DXC Technology
181 Current Jobs Openings
Apply Now

Job Description

b'


:
  • 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
Recruitment fraud is a scheme in which fictitious job opportunities are offered to job seekers typically through online services, such as false websites, or through unsolicited emails claiming to be from the company. These emails may request recipients to provide personal information or to make payments as part of their illegitimate recruiting process. DXC does not make offers of employment via social media networks and DXC never asks for any money or payments from applicants at any point in the recruitment process, nor ask a job seeker to purchase IT or other equipment on our behalf. More information on employment scams is available here.

Beware of fraud agents! do not pay money to get a job

MNCJobsIndia.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.


Related Jobs

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
 
 
Jobs by Function
Popular Job Skills
Popular Industries
Popular Cities
Jobseekers
Employers
Home | About Us | Terms & Conditions | Privacy Policy | Help and FAQ | Contact Us
All rights reserved © 2024.