Regulatory & Site Activation Specialist

Job not on LinkedIn

🕒 July 8

🇦🇺 Australia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 40%

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

• Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis and with a consistently high level of quality. • May act as a contact point for translation review of submission documents such as applications, synopses, ICFs, labels, etc. • Maintain country-specific patient information sheet and consent form customization text. • Maintain country-specific drug labeling information and Country Intelligence Pages. • Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country-specific requirements.

🎯 Requirements

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related sciences • Minimum three years of experience in clinical research, preferably in site activation and/or regulatory-related function • Previous experience within the pharmaceutical/CRO industry. • Thorough knowledge of ICH GCP, EU Clinical Trials Directive, and other relevant guidance on conducting clinical research. • Experience in regulatory submissions in Australia • Multilingualism preferred; working knowledge of English.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options