Regulatory Affairs Associate

Job not on LinkedIn

🔥 0 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 12%

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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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Support preparation, tracking, and coordination of Ethics Committee and Regulatory Authority submissions • Compile and prepare documentation required for EC and RA submissions • Track submission timelines and maintain regulatory trackers and databases • Assist with initial applications, amendments, and notifications under supervision • Coordinate with IRB/IEC and internal teams to collect required documentation • Review and format documents for consistency and completeness • Adapt country-specific informed consent forms based on master templates • Coordinate translation requests and track external vendor deliverables • Submit documents to the Trial Master File and participate in TMF reconciliation activities • Perform document archiving, status reporting, and follow-up with sites or vendors • Support review and submission of SUSARs as required by study scope • Stay informed of basic regulatory guidelines applicable to assigned countries • Participate in internal meetings and training sessions

🎯 Requirements

• Bachelor’s degree (or equivalent) in a scientific discipline • 0-2 years in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry • Experience preparing and submitting IRB/IEC packages and/or CTAs • Knowledge of applicable regional/national country regulatory guidelines and IRB/IEC regulations is an asset • Excellent knowledge of Microsoft Office suite • Proficiency in Microsoft Office Suite (Word, Excel, Outlook) • Fluency in English (oral and written) • Additional languages are an asset • Basic understanding of clinical trial processes and regulatory requirements is an asset • Strong attention to detail and organizational skills • Ability to manage multiple priorities and meet deadlines in a fast-paced environment • Willingness to learn and develop regulatory expertise under guidance • Must be legally authorized to work in Romania

🏖️ Benefits

• Permanent full-time position • Flexible schedule • Vacation • Home-based position • Ongoing learning and development • Attractive advancement opportunities