Indero is hiring a Regulatory Project Assistant (RPA) for a permanent, home-based position in India. This entry-level opportunity is suitable for graduates interested in regulatory affairs, clinical research, eTMF operations, and pharmaceutical/CRO project administration.
The Regulatory Project Assistant will provide administrative and regulatory project support to teams working across regulatory affairs, eTMF operations, Clinical Trial Information System (CTIS), ethics submissions, and clinical study documentation.
Job Title: Regulatory Project Assistant
Company: Indero
Job Type: Permanent, Full-Time
Experience: Entry-Level
Location: Home-Based – India
Industry: Clinical Research / CRO / Pharmaceutical
Function: Regulatory Affairs / Clinical Operations
Author: Pharmabharat Editorial Team
Date Posted: September 16, 2026
Indero Regulatory Project Assistant Job Description
The Regulatory Project Assistant will support regulatory project team members by maintaining documentation, updating regulatory trackers, supporting CTIS submissions, filing documents in the electronic Trial Master File (eTMF), and assisting with project administration.
The position offers an opportunity to gain practical experience in regulatory and scientific affairs while working with a global clinical research organization specializing in dermatology and rheumatology.
The role is particularly relevant for graduates looking to start a career in regulatory affairs, clinical research, clinical trial operations, eTMF, CTIS, or pharmaceutical project coordination.
Key Responsibilities
Selected responsibilities for the Regulatory Project Assistant position include:
- Upload and maintain documentation in the EMA Clinical Trial Information System (CTIS) for initial applications, amendments, and notifications.
- Maintain CTIS submission components according to applicable requirements and track regulatory timelines.
- File CTIS documentation into the electronic Trial Master File (eTMF).
- Prepare redactions of Part II and selected Part I documents for CTIS submissions.
- Prepare IRB-related documentation for eTMF filing, including approval letters, communications, and approved documents.
- Support user requests and site creation for IRB portals.
- Reconcile eTMF user-access lists with employee lists periodically.
- Prepare project documentation required for ethics and regulatory submissions.
- Maintain and update regulatory trackers for assigned clinical studies.
- Verify, reconcile, and track vendor invoices related to ethics services.
- Compile and format Clinical Study Reports (CSRs) and appendices for electronic submissions.
- Assist with PDF preparation, bookmarks, hyperlinks, and eCTD-related requirements.
- Assist with initiating, maintaining, and reviewing the eTMF.
- Support project tracking and preparation of project status reports.
- Perform additional administrative and project-support activities as required.
Eligibility and Qualifications
Candidates applying for the Indero Regulatory Project Assistant job should meet the following requirements:
Educational Qualification
- College degree or equivalent graduate-level qualification.
Experience
- Experience in an administrative support role is desirable.
- Experience in the biotechnology, pharmaceutical, clinical research, or CRO industry will be an advantage.
- The position is described as an entry-level opportunity, making it potentially suitable for graduates who have relevant academic knowledge and administrative skills.
Required Skills
Candidates should have:
- Strong written and spoken English communication skills.
- Knowledge or understanding of EU Clinical Trials Regulation (EU CTR).
- Familiarity with the Clinical Trial Information System (CTIS) and relevant business roles.
- Proficiency in Microsoft Office, particularly Microsoft Word, Excel, and Outlook.
- Knowledge of PDF editing software.
- Strong organizational and documentation-management skills.
- Ability to manage multiple short-term and long-term deliverables.
- Attention to detail and ability to meet project deadlines.
What Is CTIS?
The Clinical Trials Information System (CTIS) is the European system used for clinical trial applications and regulatory information under the EU Clinical Trials Regulation.
In this position, the Regulatory Project Assistant will support activities such as maintaining CTIS documentation, preparing submission components, tracking timelines, and filing records into the eTMF.
This makes the role relevant for candidates who want practical exposure to EU regulatory affairs and clinical trial documentation.
Benefits at Indero
According to the job description, employees in this position can receive:
- Flexible work schedule
- Permanent full-time employment
- Ongoing learning and development opportunities
- Home-based work arrangement in India
- Exposure to international clinical research and regulatory projects
- Opportunities to work collaboratively with global project teams
Candidates should note that some meetings may take place outside regular business hours, primarily during evening hours, because of the global nature of the organization.
Work Location
This is a home-based position in India.
Applicants must be legally authorized to work in India. The role may require attendance at some meetings outside regular working hours, primarily in the evening.
Salary
The job description provided by Indero does not specify a salary.
For SEO purposes, Pharmabharat estimates that an entry-level Regulatory Project Assistant position in India could potentially fall within approximately ₹3.0 lakh to ₹6.0 lakh per annum, depending on qualifications, relevant experience, skills, and the employer’s compensation structure.
Important: This is an indicative market estimate and not an officially confirmed Indero salary. Candidates should verify compensation directly during the recruitment process.
Why Consider a Regulatory Project Assistant Career?
A Regulatory Project Assistant role can provide exposure to several areas of clinical research and regulatory operations, including:
Regulatory Affairs → CTIS → EU CTR → eTMF → Ethics Submissions → Clinical Study Reports → eCTD → Project Tracking
This combination can be useful for graduates seeking career paths in regulatory operations, clinical research, clinical trial management, eTMF, regulatory submissions, and pharmaceutical operations.
How to Apply
