Specialist, Regulatory and Site Activation

Job not on LinkedIn

🔥 1 minute ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 25%

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.

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Lifelancer

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Pre Seed Round on 2022-03

Consulting • Healthcare • Logistics

Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

📋 Description

• Support regulatory submissions, site activation, and maintenance for awarded projects • Plan, initiate, and track documents required for regulatory submissions • Collect, review, and provide country, site, and ethics committee requirements • Support end-to-end site start-up from site identification through site activation and maintenance • Serve as the primary point of contact for sites and country-level regulatory and site activation activities • Customize country-specific patient information sheets, informed consent forms, labels, and local regulatory documents • Review and advise on country timelines • Communicate submission status and action plans to the Regulatory Affairs Manager and project team • Collect, receive, and perform initial reviews of study-specific site regulatory and essential documents • Track regulatory documents by site and country and follow up as needed • Identify country/site risks and develop mitigation strategies • Advise on country regulatory strategies • Maintain communication with sites to ensure timely completion of start-up and maintenance activities • Provide updates on changing regulatory requirements and support interpretation of new regulations • Maintain the regulatory intelligence database for the assigned country • Comply with SOPs, ICH GCP, and applicable regulations • Perform local quality control of submission dossiers when required • Act as a contact point for translation review of submission documents • Perform other assigned duties

🎯 Requirements

• Minimum 2-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or another related science • Minimum 2 years of experience in clinical research, preferably in site activation and/or regulatory-related function • Preferred minimum of one year of previous experience within the pharmaceutical/CRO industry • Good knowledge of ICH GCP, relevant clinical research conduct guidance, and country regulations • Fluent in the local language • Working knowledge of English • Strong organizational and management skills • Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills • Excellent written and verbal communication skills • Proficiency in Microsoft Word, Excel, and PowerPoint • Aptitude for contemporary digital systems is helpful • Ability to handle multiple tasks in a fast-paced, changing, deadline-oriented environment • Ability to prioritize and adapt between detailed and strategic activities while maintaining delivery timelines and quality • Ability to initiate and develop relationships with local investigators and key site personnel

🏖️ Benefits

• Diverse and inclusive work environment • Supportive and cohesive teams • Accessible, hands-on leadership • Equal employment opportunities • Employee experience focused on respect and inclusion