Regulatory Project Assistant

Innovaderm Research Inc.

. Provide project administrative support to regulatory project team members in regulatory affairs and eTMF operations .

Posted 9/15/2026full-timeRemote • IndiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates strong project administrative support capabilities in regulatory affairs, including proficiency in managing documentation for CTIS submissions and maintaining regulatory trackers. Possesses knowledge of EU CTR regulations and experience in the biotechnology or pharmaceutical industry.

Highest-signal resume keywords

Regulatory Affairs SupportCTIS Documentation ManagementMicrosoft Office Suite ProficiencyEU CTR Regulation KnowledgeBiotechnology Industry Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project Administrative SupportRegulatory Tracker MaintenanceDocumentation PreparationInvoice ReconciliationClinical Study Report Compilation

Soft Skills

Attention to DetailOrganizational SkillsEffective Communication

Tools & Technologies

CTIS EMA PortalETMFPDF Editor Software

Industry Keywords

BiotechnologyPharmaceuticalCRORegulatory SubmissionsIRB Portals

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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