BrightOwl Loader Loading

Regulatory Associate - Dossier - India  

Navitas Life Sciences (company)

Posted on : 22 December 2017

Project Description

Category: Executive
Location: Chennai
Job Type:
Full Time
Education: Graduate Degree

Job Description:

  • Develop a clear understanding of filing requirements for a particular product / molecule based on detailed guidance provided by Regional Dossier Strategists; serve as a thought partner to Regional Dossier Strategists to test assumptions and offer alternative solutions where appropriate.
    Identify the fastest way to compile “fit-for-purpose” dossiers, leveraging existing components (e.g., from previous filings of the same molecule in other countries) where possible.
  • Provide clear direction to partner on data needs and establish timeline and method of delivery.
  • Communicate dossier preparation timeline to Project Manager and Regional Dossier Strategists, and proactively update them on status of dossier.
  • Compile the dossier and coordinate this compilation process across multiple collaborators (e.g., Regional Dossier Strategists, In-Country Regulatory Liaisons, partner organizations).
  • Review and assess dossier readiness for filing once it is complete. Coordinate publishing of dossier with other WSRO lines.
  • Ensure that final published dossier is uploaded into appropriate Client systems (e.g., GDMS).
  • Manage preparation of Reference Safety Document for labeling for the assigned molecule. Develop best-practices to improve process and increase speed of dossier production; work with Project Managers to share and institutionalize best practices across regions

Preferred Skills:

  • Dossier preparation

If you would like to apply for this position, or would like a discussion about this, or any other role, please send your contact details, together with your curriculum vitae to: