Sr Regulatory & Start Up Specialist, Cfsp

IQVIA UK

Mexico
Fully remote
Ec submission experience in mexico
Veeva vault proficiency required
Informed consent form customization
IQVIA UK is seeking a Sr Regulatory & Start Up Specialist to oversee study planning and start-up activities for clinical projects in Mexico. The role requires a minimum of three years' experience in the biopharmaceutical or CRO industry, particularly in regulatory submissions, and demands strong communication and organizational skills

Job Summary

  • The Sr Regulatory & Start Up Specialist is accountable for study planning, SSU activities, and activation deliverables 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 responses to deficiency letters.
  • Candidates must possess a Bachelor's Degree in Life Science or equivalent experience along with a minimum of three years in the biopharmaceutical industry including EC submission in Mexico.

Matching Summary

Match Score: 85

IQVIA UK is seeking a Sr Regulatory & Start Up Specialist to oversee study planning and start-up activities for clinical projects in Mexico. The role requires a minimum of three years' experience in the biopharmaceutical or CRO industry, particularly in regulatory submissions, and demands strong communication and organizational skills.

Skills & Requirements

Must-have

  • EC submission experience in Mexico
  • Veeva Vault proficiency required
  • Informed Consent Form customization
  • IRB/IEC and Health Authority coordination
  • Novartis process compliance knowledge

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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