Senior Stem Content Analyst- Cmc (small Molecules/biologics)

Clarivate

India
Hybrid
Expertise in cmc small molecules
Experience with regulatory submissions
Ability to leverage ai-driven tools
The ideal candidate will have a solid background in pharmaceutical development and regulatory affairs

Job Summary

  • The ideal candidate will have a solid background in pharmaceutical development and regulatory affairs.
  • You will be responsible for monitoring regulatory changes and authoring detailed CMC reports.
  • The team is spread across different locations and collaborates closely with cross-functional teams.

Matching Summary

The ideal candidate will have a solid background in pharmaceutical development and regulatory affairs.

Skills & Requirements

Must-have

  • Expertise in CMC Small Molecules
  • Experience with regulatory submissions
  • Ability to leverage AI-driven tools

Nice-to-have

  • Understanding of vaccine development
  • Experience with NLP/LLMs
  • Knowledge of biological entities

Key Requirements

  • BS degree in Life Sciences
  • Minimum of 5 years in pharmaceutical development
  • Proven authorship of CTD/eCTD Module 3

Work Rights

Not specified

Tailored Resume

Cover Letter