Regulatory & Site Activation Specialist

Lifelancer

Regulatory Specialist managing regulatory submissions for clinical trials at Worldwide Clinical Trials. Ensuring compliance with ICH GCP and local regulations in Australia.

Posted 7/8/2026full-timeRemote • 🇦🇺 AustraliaMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Regulatory SubmissionsClinical ResearchICH GCPEU Clinical Trials DirectivePatient Information SheetsDrug LabelingTranslation ReviewSite ActivationDocumentation ReviewCountry-Specific Requirements