Jr Pharma. Regulatory Dossier Publisher

  • Competitive
  • Singapour, Singapore
  • CDI, Plein-temps
  • Cognizant Technology Solutions APAC
  • 17 oct. 17 2017-10-17

Jr Pharma. Regulatory Dossier Publisher

Job Summary:
Experience: 1 to 4 years
Work Location: Singapore

Job Description:

  • Global Submission/ Publishing of all submissions from a Global perspective and dispatches to worldwide Health Authorities (FDA, EMA, LATAM, ROW). Accountable for all Publishing, verification, dispatch.
  • Working in close collaboration with the Franchise Head of Global Submission Publishing and Global Submission manager, assigned to respective franchise/activity with clear accountability for publishing process.
  • Supporting implementation of Technical Format requirements and collaborates with DRA Operations Submission Standards and Strategy team members to develop company business guidance on publishing deliverables.
  • Responsible for managing all aspects related to the preparation, tracking, compilation, publishing and technical quality control of all assigned maintenance regulatory submissions for assigned franchise. Ensure adherence to internal standards and processes, as well as Health Authority's requirements.
  • Reporting and updating Franchise Head for Submission Publishing on submission progress. Providing monthly report to immediate and line management within DRA Ops. Identifying issues and solutions relating to timing, quality and resources.

Job Requirement s:

  • 1-3 years of experience in the pharmaceutical industry, with relevant experience in electronic submission publishing, dossier management and dispatch of global drug dossiers (US, EU, Asia, Latin America, etc).
  • Expert in HA submission publishing requirements globally.
  • Knowledge, of Regulatory processes and related tools (document management, publishing, etc.)
  • Excellent verbal and written communication skills.
  • Demonstrated ability to be innovative and a creative thinker.
  • Diploma/ Bachelor Degree in Pharmacy, Life Science


Qualifications
About Cognizant
Cognizant (NASDAQ-100: CTSH) is one of the world's leading professional services companies, transforming clients'​ business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant is ranked 230 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com or follow us @Cognizant.
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