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Senior Regulatory and Start Up Specialist (Brazil)

3 hours, 46 minutes ago
Brazil
Senior
Compliance Manager
Operations
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 79

Description

  • Prepare and manage clinical trial submissions, amendments, and notifications to Competent Authorities and Ethics Committees.
  • Review and adapt informed consent forms and patient information sheets for country/site use.
  • Collect, review, and maintain essential documents required for site activation and IMP release.
  • Support IRB/EC submissions and respond to questions or requests from regulatory authorities and ethics committees.
  • Maintain project plans, trackers, and regulatory intelligence tools and keep leadership updated on status and risks.
  • Coordinate with site CRAs, Clinical Operations, Project Management, Regulatory, and Site Contracts teams to align deliverables.
  • Support budget and investigator contract negotiations with the Site Contract Management group as needed.
  • Act as a subject matter expert on country start-up activities, regulations, and critical path timelines.
  • Train and mentor less-experienced staff on submissions, procedures, and local start-up requirements.
  • Maintain audit and inspection readiness and file documents in the TMF according to study plans.

Requirements

  • Bachelor’s degree in life sciences or a related scientific/healthcare field, or Registered Nurse, or equivalent education, training, and experience.
  • 3.5+ years of experience as a Regulatory or site start-up specialist in CRO, pharmaceutical, or biotech environments.
  • Professional-level English communication skills, both written and verbal.
  • Fluency in English and, for non-English-speaking countries, the local language of the country where the role 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.
  • Preferred: country-specific regulatory and site start-up experience, including feasibility, contract negotiations, and CA/EC/IRB submissions.
  • Preferred: experience using milestone tracking tools/systems, plus advanced degree (MD, PhD, PharmD), RAC certification, or Master’s in Regulatory Science.

Benefits

  • Remote work is indicated by the posting (#LI-REMOTE).
  • Opportunity to join as the first Senior Regulatory and Start Up Specialist in Brazil.
  • Occasional travel may be required.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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