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Regional Submission Planner

Introduction

Would you like the opportunity to work in a dynamic, young environment? Are you interested in your personal growth, as well as your career’s?


Tata Consultancy Services (TCS) is an IT services, consulting, and business solutions provider that has been partnering with the world’s largest businesses in their transformation journeys.

Function

In our Life Science Department, you will work within the Client organization, in the Regulatory Affairs Operations Regional department (EMEA Region).


The Regulatory Submissions Planner will:


  • Support the regulatory submission creation and the registration tracking of the company, the regulatory submission targets from a regulatory operational perspective for the whole region.
  • Review and manage the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs of regional regulatory authority.
  • Help with project management tasks, including managing dynamic timelines, interacting and negotiating and collaborating with global stakeholders


Your main functions would be:


  • Manage Operations aspects of submission planning for assigned products;
  • submission planning
  • document retrieval
  • submission creation and delivery to Health Authorities

Requirements

Required for this role:


  • Bachelor’s degree in a Life Science related discipline.
  • High level expertise and knowledge of the regulatory landscape, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).
  • Affinity to work with complex IT systems
  • English language knowledge, intermediate or above
  • At least 2 years experience in the regulatory operations area, regulatory affairs will be an asset.

Offer

Why choose TATA?


In our Shared Service Center you can taste the world by working together with more than 90 nationalities. As part of the Tata Group, India’s largest multinational business group, TCS has over 450,000 of the world’s best-trained consultants in 46 countries.


This position belongs to the BPS (Business Process Solutions) unit. This unit is helping enterprises achieve significant and sustained business outcomes by leveraging our deep domain expertise and operations.


As a future TCSer, you will be provided with:

  • A career path that will allow you to become a Subject Matter Expert
  • The opportunity to work on different Pharmacovigilance/Regulatory processes across different projects
  • Trainings on various competencies and skills
  • Language courses and training
  • On-site relax & gym rooms
  • Volunteering, sport and employee events

Information

Elena Berlingeri

Email: e.berlingeri@tcs.com

Mobile: +36 301658601


Egmily Sanchez

Email: egmily.s@tcs.com

Mobile: +36 30 174 2006


Application

Elena Berlingeri

Email: e.berlingeri@tcs.com

Mobile: +36 301658601


Egmily Sanchez

Email: egmily.s@tcs.com

Mobile: +36 30 174 2006