ASSISTANT MANAGER

Biocon

  • India
  • Permanent
  • Full-time
  • 16 days ago
Department DetailsRole SummaryRESPONSIBILITIES:
  • Strong understanding of eCTD, NeeS, and ICH guidelines.
  • Familiarity with Regulatory systems and Publishing tools.
  • Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe
Acrobat, MS Excel, SharePoint.
  • Ability to perform end-to-end eCTD submission process, including Document level
Publishing and Dossier compilation, and dispatch of submissions to respective Health
Authorities (Developed and ROW Markets)
  • Manage lifecycle submissions including variations, amendments, and renewals.
  • Perform document-level publishing, hyperlinking, bookmarking, and validation.
  • Conduct quality control checks to ensure submission readiness.
  • Collaborate with cross-functional teams including Regulatory Affairs, CMC, and
Clinical.
  • Stay updated with global regulatory guidelines (ICH, FDA, EMA).
  • Detail-oriented with a collaborative mindset
Key ResponsibilitiesRESPONSIBILITIES:
  • Strong understanding of eCTD, NeeS, and ICH guidelines.
  • Familiarity with Regulatory systems and Publishing tools.
  • Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe
Acrobat, MS Excel, SharePoint.
  • Ability to perform end-to-end eCTD submission process, including Document level
Publishing and Dossier compilation, and dispatch of submissions to respective Health
Authorities (Developed and ROW Markets)
  • Manage lifecycle submissions including variations, amendments, and renewals.
  • Perform document-level publishing, hyperlinking, bookmarking, and validation.
  • Conduct quality control checks to ensure submission readiness.
  • Collaborate with cross-functional teams including Regulatory Affairs, CMC, and
Clinical.
  • Stay updated with global regulatory guidelines (ICH, FDA, EMA).
  • Detail-oriented with a collaborative mindset
Educational QualificationsRequired Education Qualification: M.Sc
Required Experience: 6 - 10 years

Biocon