Senior Regulatory and Start Up Specialist, Mexico

🔥 11 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Deliver timely, high-quality site activation readiness for assigned Mexico sites and mitigate risks • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees and other local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide submission updates to Start Up/Regulatory Leads and Project Managers/teams • Maintain project plans, trackers and regulatory intelligence tools • Support study-specific start-up plans, IMP release requirements and essential document review criteria • Partner with site CRAs to align communication and secure site collaboration • Prepare, review and manage essential documents for site activation and IMP release • Customize country/site-specific Patient Information Sheets and Informed Consent Forms • Coordinate document translations • Communicate with Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts teams • Act as subject matter expert for site activation critical-path data, timelines, contracts and budget requirements • Support study budget negotiations and investigator contract execution • Maintain knowledge of local clinical trial laws and regulations and distribute regulatory knowledge • Maintain audit/inspection readiness and file documents in the relevant TMF • Support pre-study site visits, feasibility outreach, country start-up summaries, training, mentoring and client updates as required • Perform other duties assigned by management

🎯 Requirements

• Bachelors’ degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience • 3.5 years or more as a Regulatory or Site Start-Up specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies • Professional-level English proficiency • Fluency in English and the local language of the country where the position is based • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail • Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements • Excellent communication, organizational, presentation and interpersonal skills • Ability to prioritize workload and meet deadlines • Ability to work independently in a fast-paced environment • Excellent computer skills • Occasional travel may be required • Must be legally authorized to work in the country of employment without employer sponsorship