Regulatory Project Assistant

Job not on LinkedIn

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 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

• Provide project administrative support to regulatory project team members in regulatory affairs and eTMF operations • Upload and maintain documentation in the CTIS EMA portal for initial applications, amendments, and notifications • Maintain submission components and track regulatory timelines • File CTIS documentation to the eTMF • Prepare redactions of Part II and selected Part I documents for CTIS submission • Prepare IRB-related documentation for eTMF filing • Support user requests and site creation for IRB portals • Reconcile eTMF user access lists against employee lists periodically • Prepare project documentation for ethics and regulatory submissions • Prepare, maintain, and update regulatory trackers for assigned studies • Verify, reconcile, and track vendor invoices for ethics services • Compile and format Clinical Study Reports and appendices for electronic submissions, including PDFs, bookmarks, hyperlinks, and eCTD • Assist with initiating, maintaining, and reviewing the eTMF • Assist with project tracking activities and status report preparation • Perform other administrative tasks required by project goals and team needs

🎯 Requirements

• College Degree • Experience working in an administrative support-type of role • Experience in the biotechnology, pharmaceutical, and/or CRO industry is an asset • Proficiency in English (written and oral) required • Knowledge and understanding of EU CTR regulation and CTIS business role • Knowledge and competency with Microsoft Office suite (Word, Excel, Outlook) • Knowledge and competency with PDF editor software • Must be legally able to work in India • Attendance at some meetings outside of regular business hours, primarily in the evening, is required

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Ongoing learning and development • Home-based work arrangement in India