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Senior Regulatory and Start Up Specialist (Mexico)

1 hour, 52 minutes ago
Mexico
Full-time
Senior
Operations Specialist
Project and Program Management
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 124

Description

  • Deliver site activation readiness for assigned country sites, including timeliness, quality, and risk mitigation.
  • Prepare clinical trial application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage initial submissions, amendments, and notifications to secure required study authorizations and approvals.
  • Interact with Competent Authorities and Ethics Committees and handle their responses.
  • Provide regular submission status updates to the Start Up Lead, Regulatory Lead, Project Manager, and project team.
  • Maintain project plans, trackers, and regulatory intelligence tools and keep Regulatory Leadership informed.
  • Prepare and support study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs and key functions such as feasibility, clinical operations, project management, regulatory, and site contracts.
  • Prepare, review, and manage essential documents for site activation and IMP release.
  • Customize patient information sheets and informed consent forms and coordinate required translations.
  • Support site contract management with budget and investigator contract negotiations when needed.
  • Serve as a subject matter expert, trainer, and mentor on country-specific start-up activities and regulations.
  • Maintain audit and inspection readiness and file documents in the TMF according to study plans.
  • Support pre-study site visits, feasibility outreach, training sessions, client updates, and proposal activities as needed.

Requirements

  • Bachelor’s degree in life sciences or a related scientific/healthcare field, or Registered Nurse, or an equivalent combination of education, training, and experience.
  • 3.5+ years of experience as a Regulatory or Site Start-Up specialist in a CRO or pharmaceutical/biotech environment, or equivalent relevant experience.
  • Professional-level English communication skills, both verbal and written.
  • Fluency in English and, for non-English speaking countries, the local language of the country where the position is based.
  • Excellent communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Ability to prioritize workload and meet deadlines.
  • Knowledge of Good Clinical Practice, ICH guidelines, and applicable regulatory requirements.
  • Experience with regulatory and site start-up activities such as feasibility, contract negotiations, and CA/EC/IRB submissions is preferred.
  • Experience using milestone tracking tools or systems is preferred.
  • Ability to assist junior start-up specialists with problem resolution is preferred.
  • Advanced degree in medical or life sciences, RAC certification, or a Master’s in Regulatory Science is preferred.
  • Strong attention to detail and accuracy.
  • Excellent computer skills.
  • Ability to work independently in a fast-paced environment.
  • Occasional travel may be required.

Benefits

  • Remote work designation (#LI-REMOTE).
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.
  • Privacy policy and applicant privacy notice protections for submitted data.

Interested in this position?

Apply directly on the company website

Apply Now

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