Specialist, Study Start Up & Regulatory Affairs

🔥 2 hours ago

🌐 New Zealand, Serbia – Remote

🇳🇿 New Zealand – Remote 🇷🇸 Serbia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 16%

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

ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Complete study start-up and regulatory deliverables based on an established SSU RA management plan • Serve as liaison between SSU/regulatory project teams, authorities, vendors, and investigative sites • Independently manage low-complexity study start-up activities under senior team guidance • Prepare, collect, review, and submit regulatory information to national authorities and ECs/IRBs • Collect, review, and track essential documents for study start-up and site activation • Investigate incomplete, inaccurate, or missing documents • Prepare study team reports and updates on document collection, review, and approval status • Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments • Conduct site outreach and manage confidential disclosure agreements • Coordinate document processing with study teams, sponsors, clinical monitoring, clinical contracts, and other functions • Review labels, patient information sheets, diary cards, insurance, and other documentation for ICH GCP and country-specific compliance • Arrange and/or review translations of essential documents • Contribute to regulatory and study start-up strategies and SSU plans • Complete project trackers, study portal and TMF filing, and submission dossier quality control • Ensure deliverables and essential document submissions meet project timelines, expectations, SOPs, and study-specific requirements

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Pharmacy, MD, or equivalent combination of education and experience • Previous experience within the pharmaceutical/CRO industry • Good knowledge of ICH GCP and national regulations for territories of competency • Good written and verbal communication skills • Proficiency in English, both written and verbal

🏖️ Benefits

• Remote work availability • Work-life balance • Collaborative, international team environment • Career growth opportunities • Trusted ownership and flexibility • Passionate and collaborative team of experts • Opportunity to help bring safe and effective pharmaceutical treatments to patients around the world