Specialist, Regulatory Affairs

World Courier

1 - 6 years

5 - 8 Lacs

noida

Posted:1 day ago| Platform:

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Skills Required

adobe acrobat publishing pdf software validation quality check consulting project planning troubleshooting microsoft powerpoint

Work Mode

Work from Office

Job Type

Full Time

Job Description

To ensure that the clients are fully supported in all regulatory submissions with assistance from the manager or other senior team member.
To function with a degree of independence and is responsible for creating eSubmission compliant documents and submissions, troubleshooting, with help from the manager as required.
Formatting in Microsoft Word, making PDF files eSubmission compliant using specialized Adobe Acrobat plug-ins, using e-validator to quality check th and utilizing eCTD creation software to prepare high quality submission.

Primary Duties and Responsibilities:

Build and maintain a positive and productive liaison with internal and external contacts,
including interfacing with potential clients.
Use various company and client tools for preparation / maintenance / tracking of eSubmissions
Create and format eSubmission documents as per clients needs using Microsoft Word,
Adobe Acrobat (and associated plug-ins), Excel, Power Point.
Create submissions using eCTD creation software, validation and submission to Health Authorities via eSubmission portals.
Create NeeS, and paper submissions as needed.
Trouble shoot and fix issues, on a document and submission level with little assistance from the manager.
Attend and contribute to weekly department meetings.
Maintain professional regulatory and documentary knowledge to provide effective consulting advice.
The Specialist may be asked to complete additional and other departmental services as required

Minimum Skills, Knowledge and Ability Requirement:

High-level understanding of regulatory processes and CTD dossier structure - Modules 1 to 5.
Prior experience with eDMs, RIM tools or eCTD publishing software like docuBridge, eCTD manager, Veeva or other, is not required but is an advantage.
Ability to work according to project plan and escalate potential issues according to agreed communication plan.
Structured way of working; limited latitude within established set of procedures, may determine priorities with general supervision.
Resolves routine (and some non-routine) problems in a thorough and timely manner. Attention to detail. High service orientation.
Ability to prioritize and manage own time and tasks.
Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise. Confident appearance.
English business fluent.

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