Regulatory Affairs Specialist

Lonza Group

Hyderabad, India
Degree in chemistry, biology or life sciences
Strong knowledge of global regulatory requirements
Experience with veeva vault and ectd publishing
The role involves supporting site and customer related regulatory dossier activities for clinical trial applications

Job Summary

  • The role involves supporting site and customer related regulatory dossier activities for clinical trial applications.
  • Candidates will write CMC regulatory dossiers ensuring accuracy, completeness, and compliance using source documents.
  • The position offers opportunities to collaborate with global cross-functional teams within an inclusive and ethical workplace.

Matching Summary

The role involves supporting site and customer related regulatory dossier activities for clinical trial applications.

Skills & Requirements

Must-have

  • Degree in Chemistry, Biology or Life Sciences
  • Strong knowledge of global regulatory requirements
  • Experience with Veeva Vault and eCTD publishing
  • Proficiency in CMC documentation for clinical submissions

Nice-to-have

  • Collaborative and proactive mindset
  • Strong project management skills
  • Excellent communication and stakeholder influence

Key Requirements

  • Degree in Chemistry, Biology, or related Life Sciences discipline
  • Experience with document management systems like Veeva
  • Business fluency in English

Work Rights

Not specified

Tailored Resume

Cover Letter