Global Submission Associate

Sanofi Genzyme

Morristown, NJ, United States
Base: $75,000.00 - $108,333.33; bonus/equity: not ...
Onsite
3+ years pharmaceutical regulatory experience
Proficiency in ectd publishing tools
Knowledge of us, canada, or eu submission requirements
The Global Submission Associate coordinates lifecycle submissions for the global portfolio ensuring they meet Health Authority specifications on time

Job Summary

  • The Global Submission Associate coordinates lifecycle submissions for the global portfolio ensuring they meet Health Authority specifications on time.
  • Candidates will partner with stakeholders and third-party vendors to execute complex submission plans using content re-use strategies.
  • Sanofi offers a thoughtful rewards package including high-quality healthcare, wellness programs, and at least 14 weeks' gender-neutral parental leave.

Matching Summary

The Global Submission Associate coordinates lifecycle submissions for the global portfolio ensuring they meet Health Authority specifications on time.

Salary

Base: $75,000.00 - $108,333.33; Bonus/Equity: Not specified; Benefits: Eligible for company employee benefit programs

Skills & Requirements

Must-have

  • 3+ years pharmaceutical regulatory experience
  • Proficiency in eCTD publishing tools
  • Knowledge of US, Canada, or EU submission requirements
  • Module 4 and 5 dossier assembly expertise
  • Bachelor's degree in regulatory affairs or sciences

Nice-to-have

  • Experience with Veeva RIM systems
  • Understanding of EMA work sharing processes
  • Ability to troubleshoot technical validation issues
  • Strong cross-cultural collaboration skills
  • Agile approach to dynamic global environments

Key Requirements

  • Bachelor's degree required
  • Minimum 3 years industry experience
  • Direct regulatory affairs background mandatory
  • eCTD publishing tool proficiency essential
  • Regional submission knowledge (US/Canada/EU) required

Work Rights

Not specified

Tailored Resume

Cover Letter