Ora, Inc Company announces a new job opportunity: Application deadline is March 9 تعلن شركة Ora, Inc عن فرصة عمل جديدة: الموعد لتقديم الطلبات هو 9 مارس - - الكويت

وصف الوظيفة

Kuwait Jobs Today Ora, Inc Company announces new job opportunities. Are you looking for job opportunities in Kuwait? Ora, Inc Company announces the opening of recruitment for many jobs in various specializations in Kuwaiton today's date. These opportunities are available to all nationalities. Learn about the available jobs and how to apply through the following advertisement.

Required jobs in Ora, Inc company and their details:

Regulatory Operations Specialist II

About the job

POSITION TITLE: Regulatory Operations Specialist II

DEPARTMENT: Ora Europe

LOCATION: UK or Europe

Ora Values the Daily Practice of...

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

The Role:


The Regulatory Operations Specialist is responsible for assisting the Regulatory submissions team in QC, coordination of document preparation, management, and submissions within (and around) Europe. This is a team and individual contributor role, reporting to the Manager of Regulatory. This position will work collaboratively with regulatory, country CRA and project team. This position requires a strong technical background, a high degree of enthusiasm, enjoyment of working in a fast-paced environment, being self-motivated, and being able to use critical reasoning to solve problems and make decisions.

What You’ll Do:

Under the supervision of the European Regulatory Manager:


Performs the role of a Regulatory Lead for studies within the European region during study start-up until study close out
Oversees and performs quality control checks on clinical and regulatory documents, including Patient Information Sheet (PIS)/Informed Consent Form (ICF)
Responsible for and contributes to preparation and submission of documents to regulatory authorities and ethics committees, primarily within the Clinical Trial Information System (CTIS)
Performs quality control checks on study documents that are received from the sponsor and/or prepared by country CRAs to ensure all submission documents meet Ora’s submission standards
Oversees, coordinates and contributes to development of country adapted study documents and ensuring documents are sponsor approved prior to finalization
Contributes to the review and revision of standard operating procedures (SOPs), templates, and forms
Performs data entry for tracking of regulatory submission activities
Updates tracking logs, databases, and ensure filing of country adapted and sponsor approved study documents are filed in collaborative workspace


Prepares the clinical trial application within CTIS for Part I with supervision; in compliance with forecasted timelines
Escalates potential issues identified to impact forecasted timelines quickly
May be required to provide regulatory support in other regions
Keep up to date with current regulations, guidelines and changes in the industry
Collaboration with Global Regulatory team and wider stakeholders
Responsibilities may differ slightly from the above based on specific needs of the business. 
Clear and sustained demonstration of the Ora Clinical’s Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor. 

How to apply for jobs

To apply for the aforementioned jobs, you can follow these steps:

  1. To go to the application page. (Job opportunities for Ora, Inc Company)
  2. Click on a job title to view details.
  3. Please click the Easy Apply button at the top of the page.
  4. Enter the required information in the pop-up screens.
  5. Click Review to review the form.

Source and additional details

  • Job source: The official website of the company
  • Posted Date: 9-3-2024 (Please check the date before applying).
  • Required Nationalities: All nationalities.

تذكير هام جدا! ان لم تكن هذه الوظائف مناسبة لك .. يمكن الاطلاع علي 2000 وظيفة خالية فى الكويت اليوم مقسمة بالتخصصات من الرابط التالى وظائف خالية فى الكويت اليوم

متطلبات الوظيفة

  • سنوات خبره

    غير محدد

  • الجنس المطلوب

    غير محدد

  • اللغة الانجليزية

    أساسيات

  • السن المطلوب

    غير محدد

  • المستهدفين

    غير محدد

  • نوع التعاقد

    غير محدد

  • المستوى المهنى

    غير محدد

  • المستوى التعليمى

    غير محدد

  • الجنسيات المطلوبة :

    غير محدد

  • مايكروسوفت أوفيس

    جيد جدا

الراتب ونوع العمل

  • المرتب

    غير محدد

  • نوع التوظيف

    غير محدد

مميزات الوظيفة

1 / 3
Caption Text

رابط مختصر للوظيفة https://www.kuwaitjobstoday.com/go/?p=74786

برجاء توخى الحذر من اعلانات النصب والاحتيال , الوظائف الحقيقيه لاتحتاج دفع اى رسوم او اموال عند التقدم لها. الموقع غير مسئول عن مثل هذة الاعلانات لذلك نرجو الابلاغ عن الوظائف الوهميه ليتم حذفها فورا

‏وظائف الكويت اليوم‏