Regulatory Project Assistant-India

The Regulatory Project Assistant (RPA) is responsible for providing project administrative support to the regulatory project team members (regulatory affairs, eTMF operations). The RPA also supports activities within the regulatory website Clinical Trial Information System (CTIS) ensuring completeness and timely entry of information for EU submissions.

The RPA properly manages personal timelines and workload distribution between short term and long term deliverables such that all project deadlines are respected.

This role will be perfect for you if

• You want to have an experience in regulatory and scientific affairs;

• You want to work in a collaborative environment;

• You want to have an impact in a fast-growing company

RESPONSIBILITIES

More specifically, the Regulatory Project Assistant :

• Uploads and maintains documentation in CTIS EMA portal for initial applications, amendments, and notifications. Maintains submission components in accordance with requirements and tracks timelines

• Files CTIS documentation to the eTMF

• Prepares redaction of Part II and selected Part I documents for CTIS submission.

• Prepares IRB-related documentation for eTMF filing (eg, approval letters, communications, and approved documents from IRB portals)

• Supports user requests and site creation for IRB portals

• Supports the reconciliation of eTMF user access lists against employee list on a periodic basis.

• Prepares project documentation for ethics and regulatory submissions

• Prepares, maintains, and updates regulatory trackers for assigned studies

• Verifies, reconciles, and tracks vendor invoices for ethics services

• Compiles and formats Clinical Study Reports (CSRs) and appendices as per requirements for electronic submissions (eg, PDF, bookmarks, hyperlinks, eCTD).

• Assists with initiating, maintaining, and reviewing the eTMF

• Assists with project tracking activities and status reports preparation

• Participates in various administrative tasks, as required, to accomplish the goals of the project and the needs of the project teams

• Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

IDEAL PROFILE

Education

• College Degree;

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Experience

• Experience working in an administrative support-type of role;

• Experience in the biotechnology, pharmaceutical, and/or CRO industry, an asset;

Knowledge and skills

• 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;