Senior Regulatory And Start Up Specialist (mexico)

Precision Medicine Group

Mexico
**
Clinical trial submission to competent authorities
Ethics committee submissions
Informed consent form review
** Precision Medicine Group is seeking a Senior Regulatory and Start-Up Specialist in Mexico to oversee clinical trial submissions and ensure compliance with regulations. The ideal candidate will have extensive experience in regulatory processes, strong communication skills, and the ability to manage site activation readiness. **

Job Summary

  • Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
  • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities (CA), Ethics Committee (EC) and other applicable local bodies.
  • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within Precision for Medicine to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.

Matching Summary

Match Score: 75

** Precision Medicine Group is seeking a Senior Regulatory and Start-Up Specialist in Mexico to oversee clinical trial submissions and ensure compliance with regulations. The ideal candidate will have extensive experience in regulatory processes, strong communication skills, and the ability to manage site activation readiness. **

Skills & Requirements

Must-have

  • Clinical trial submission to Competent Authorities
  • Ethics Committee submissions
  • Informed Consent Form review
  • Essential Document collection and review
  • ICH-GCP compliance

Nice-to-have

  • Subject Matter Expert for site start-up
  • Training less-experienced staff
  • Country-specific tools and guidance documents
  • Client interaction for status updates

Key Requirements

  • 3.5 years of experience as Regulatory or SU specialist
  • Bachelors’ degree in life sciences or related field, RN, or equivalent
  • English proficient (Professional level)

Work Rights

Not specified

Tailored Resume

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