Manager - Ra

Lupin Ltd

Airoli, MH, India
On-site
Prepare eanc dossiers
Respond to eanc queries
Liaise with cross-functional teams
Review and guide the team in preparing dossiers for Europe, Australia, New Zealand, and Canada (EANC) regions

Job Summary

  • Review and guide the team in preparing dossiers for Europe, Australia, New Zealand, and Canada (EANC) regions.
  • Liaise with R&D, manufacturing plants, clinical teams, and respective EANC offices/BD teams.
  • Regularly study regulatory guidelines and stay updated on Electronic eCTD (electronic Common Technical Document) requirements.

Matching Summary

Review and guide the team in preparing dossiers for Europe, Australia, New Zealand, and Canada (EANC) regions.

Skills & Requirements

Must-have

  • Prepare EANC dossiers
  • Respond to EANC queries
  • Liaise with cross-functional teams
  • Support product lifecycle management
  • Study regulatory guidelines
  • Maintain departmental databases

Nice-to-have

  • Innovation & Creativity
  • Result Orientation
  • Collaboration
  • Customer Centricity
  • Developing Talent
  • Stakeholder Management
  • Strategic Agility
  • Process Excellence

Key Requirements

  • Electronic eCTD requirements
  • GMP applications submission

Work Rights

Not specified

Tailored Resume

Cover Letter