Sr Regulatory & Start Up Specialist, Cfsp

IQVIA Inc

Mexico
**
Ec submission experience in mexico
Icf customization expertise
Veeva vault proficiency
** The Sr Regulatory & Start Up Specialist position at IQVIA Inc. in Mexico is a home-based role focused on managing study start-up activities and ensuring compliance with regulatory requirements for clinical trials. The ideal candidate will have a strong background in the biopharmaceutical sector, particularly in ethical committee submissions and project management. **

Job Summary

  • The Sr Regulatory & Start Up Specialist is accountable for leading all study start-up activities from country allocation until the Green Light milestone in compliance with Novartis processes and GCP/ICH requirements.
  • This role requires close collaboration with local IRBs, IECs, and Health Authorities to ensure timely preparation of submission packages and resolution of deficiency letters.
  • The incumbent must ensure inspection readiness of country TMF documents while adhering to financial standards and implementing innovative processes aligned with company strategy.

Matching Summary

Match Score: 75

** The Sr Regulatory & Start Up Specialist position at IQVIA Inc. in Mexico is a home-based role focused on managing study start-up activities and ensuring compliance with regulatory requirements for clinical trials. The ideal candidate will have a strong background in the biopharmaceutical sector, particularly in ethical committee submissions and project management. **

Skills & Requirements

Must-have

  • EC submission experience in Mexico
  • ICF customization expertise
  • Veeva Vault proficiency
  • GCP/ICH regulatory compliance
  • IRB/IEC submission package preparation

Nice-to-have

  • Ability to negotiate complex contracts
  • Proactive issue identification skills
  • Experience with EU-CTR regulations
  • Strong stakeholder collaboration abilities
  • Self-starter with independent work capability

Key Requirements

  • Bachelor's Degree in Life Science or equivalent
  • Minimum 3 years biopharmaceutical/CRO industry experience
  • Fluent English written and oral communication skills
  • Specific EC submission experience in Mexico required

Work Rights

Not specified

Tailored Resume

Cover Letter