Indero, formerly known as Innovaderm, is hiring for the position of Regulatory Project Assistant (RPA) in India. This is a permanent, full-time, entry-level opportunity for candidates interested in regulatory affairs, scientific affairs, and clinical research operations.
The position involves supporting regulatory project teams, maintaining documentation in the Clinical Trials Information System (CTIS), assisting with electronic Trial Master File (eTMF) activities, and preparing documentation for ethics and regulatory submissions. The role is home-based in India.
Job Details
| Particulars | Details |
|---|---|
| Company | Indero (formerly Innovaderm) |
| Job Title | Regulatory Project Assistant (RPA) |
| Job Location | India |
| Work Mode | Home-based |
| Employment Type | Permanent, Full-time |
| Experience Level | Entry-level |
| Department | Regulatory Affairs / eTMF Operations |
| Industry | Clinical Research / CRO |
| Work Schedule | Flexible work schedule |
| Working Hours | Some evening meetings outside regular business hours |
| Official Website | https://www.indero.com/ |
Position: Regulatory Project Assistant
The Regulatory Project Assistant provides administrative and project coordination support to regulatory affairs and eTMF operations teams. The role also supports the management of clinical trial documentation and the timely entry of information required for European Union clinical trial submissions through the CTIS portal.
Responsibilities
Selected candidates will be responsible for the following activities:
- Uploading and maintaining documentation in the CTIS portal for initial applications, amendments, and notifications.
- Tracking regulatory submission components and ensuring documentation meets applicable requirements and timelines.
- Filing CTIS documentation in the electronic Trial Master File (eTMF).
- Preparing redacted versions of Part II and selected Part I documents for CTIS submissions.
- Preparing ethics committee and Institutional Review Board (IRB) documentation for eTMF filing.
- Supporting user requests and site creation for IRB portals.
- Reconciling eTMF user access lists with employee lists periodically.
- Preparing project documentation for ethics and regulatory submissions.
- Maintaining and updating regulatory trackers for assigned studies.
- Verifying, reconciling, and tracking vendor invoices related to ethics services.
- Compiling and formatting Clinical Study Reports (CSRs) and appendices for electronic submissions, including PDF files, bookmarks, hyperlinks, and eCTD requirements.
- Assisting with the initiation, maintenance, and review of the eTMF.
- Supporting project tracking activities and preparing status reports.
- Performing additional administrative tasks required to support project teams.
Eligibility and Qualifications
Candidates applying for the Regulatory Project Assistant position should meet the following requirements:
- Education: College degree.
- Administrative Experience: Experience in an administrative support role.
- Industry Experience: Experience in the biotechnology, pharmaceutical, or CRO industry is an asset.
- Work Authorization: Applicants must be legally eligible to work in India.
Required Skills
Candidates should possess the following knowledge and skills:
- Proficiency in written and spoken English.
- Knowledge and understanding of EU Clinical Trials Regulation (EU CTR).
- Understanding of CTIS business roles.
- Competency in Microsoft Office applications, including Word, Excel, and Outlook.
- Knowledge of PDF editing software.
- Ability to manage personal timelines and balance short-term and long-term deliverables while meeting project deadlines.
