Sr Regulatory & Start Up Specialist, Cfsp

IQVIA

Mexico
**
Ec submission experience in mexico
Veeva vault proficiency required
Irb/iec submission package preparation
** IQVIA is seeking a Senior Regulatory & Start-Up Specialist to manage study planning and start-up activities for clinical trials in Mexico. The role requires a minimum of three years of experience in the biopharmaceutical or CRO industry, with a focus on regulatory submissions and collaboration with local authorities. **

Job Summary

  • The Sr Regulatory & Start Up Specialist is accountable for planning and executing study start-up activities in compliance with Novartis processes and GCP/ICH requirements.
  • This role involves leading all SSU activities, collaborating with local IRBs/IECs and Health Authorities, and ensuring timely submission packages are prepared and finalized.
  • Candidates must possess a Bachelor's Degree in Life Science and a minimum of three years of relevant experience in the biopharmaceutical industry with specific EC submission experience in Mexico.

Matching Summary

Match Score: 75

** IQVIA is seeking a Senior Regulatory & Start-Up Specialist to manage study planning and start-up activities for clinical trials in Mexico. The role requires a minimum of three years of experience in the biopharmaceutical or CRO industry, with a focus on regulatory submissions and collaboration with local authorities. **

Skills & Requirements

Must-have

  • EC submission experience in Mexico
  • Veeva Vault proficiency required
  • IRB/IEC submission package preparation
  • Informed Consent Form customization
  • Health Authority engagement skills

Nice-to-have

  • Ability to negotiate complex contracts
  • Proactive issue identification skills
  • Experience with EU-CTR regulations
  • Strong independent work ethic
  • Fluent English communication skills

Key Requirements

  • Bachelor's Degree in Life Science or equivalent
  • Minimum 3 years biopharma/CRO experience
  • Specific EC submission experience in Mexico
  • Fluent written and oral English
  • Proficiency with Veeva Vault and Microsoft Office

Work Rights

Not specified

Tailored Resume

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