Regulatory Project Assistant

This is a fully remote position, open to applicants in India.

📋 Description

• Offer administrative support to members of the regulatory project team involved in regulatory affairs and eTMF operations.

• Upload and manage documentation in the CTIS EMA portal for initial applications, amendments, and notifications.

• Oversee submission components and monitor regulatory timelines.

• Organize CTIS documentation within the eTMF.

• Prepare redacted versions of Part II and selected Part I documents for CTIS submission.

• Generate IRB-related documentation for eTMF filing.

• Assist with user requests and the creation of sites for IRB portals.

• Periodically reconcile eTMF user access lists with employee lists.

• Compile project documentation necessary for ethics and regulatory submissions.

• Create, maintain, and update regulatory trackers for designated studies.

• Verify, reconcile, and monitor vendor invoices related to ethics services.

• Gather and format Clinical Study Reports and appendices for electronic submissions, ensuring inclusion of PDFs, bookmarks, hyperlinks, and eCTD.

• Aid in the initiation, maintenance, and review of the eTMF.

• Support project tracking activities and the preparation of status reports.

• Execute other administrative tasks as required by project objectives and team needs.

⛳️ Requirements

• Bachelor's Degree.

• Experience in an administrative support role.

• Background in the biotechnology, pharmaceutical, and/or CRO industry is preferred.

• Proficient in English (both written and spoken) is essential.

• Familiarity with EU CTR regulations and the CTIS business framework.

• Competency in Microsoft Office Suite (Word, Excel, Outlook).

• Proficiency with PDF editing software.

• Must have legal authorization to work in India.

• Availability for some meetings outside of standard business hours, primarily in the evening, is necessary.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time employment.

• Opportunities for continuous learning and development.

• Home-based work arrangement in India.