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Submission Publisher

Introduction

Regulatory submission is the process through which pharmaceutical companies submit the information about their newly developed healthcare product to a regulatory agency for review.

Function

Roles and Responsibilities:

· The Regulatory Submission Publisher is responsible for the compilation, publishing, and technical quality control of Regulatory submissions including technical troubleshooting to ensure issues with submissions are resolved and deadlines met.

· Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch documents according to regulatory requirements for paper and electronic submissions

· QC electronic and paper submissions to ensure compliance with company and agency requirements

· Support regulatory submissions publishing Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP), Centralized Procedure (CP) and National filing for the EU. Mutual Recognition Procedure (MRP): A Marketing authorization in one Member State ought in principle to be recognized by the authorities of other member States. Decentralized Procedure (DCP) :If a market authorization applicant is not granted authorization by any of the European Union (EU) member states, and is aiming for procuring authorization in multiple selected EU member states, then they can approach the Health Authority (HA) through Decentralized Procedure (DCP). Centralized Procedure (CP) The European Union-wide procedure for the authorization of medicines, where there is a single application, a single evaluation and a single authorization throughout the European Union. Only certain medicines are eligible for the centralized procedure

· Regular interaction with internal stakeholders and external stakeholders for smooth workflow

Requirements

Academic Qualification:

· Masters (preferred) or Bachelors’ Degree in Life Sciences or Pharmacy

Experience:

· 6months-12months of experience in submissions for EU regions

· Experience in submission publishing tools like Insight Publisher and other leading electronic publishing tools


Others:

· Able to work independently, guided by procedures, with appropriate support.

· Able to work effectively as part of a team.

· Attention to details.

· Excellent interpersonal and communication skills.

· Ability to prioritize, schedule and organize.

· Good time management.

Offer

We offer a colorful and dynamic work environment with:

  • market competitive compensation package
  • a great diversity of people, cultures, and business areas
  • language courses and training
  • global and diverse working environment
  • on-site relax & gym rooms
  • volunteering, sport and employee events

Information

Elena Berlingeri

Email: e.berlingeri@tcs.com

Mobile: +36 301658601


Andrea Ignatakova

Email: andrea.ignatakova@tcs.com

Mobile: +36 30 448 3561

Application

Elena Berlingeri

Email: e.berlingeri@tcs.com

Mobile: +36 301658601


Andrea Ignatakova

Email: andrea.ignatakova@tcs.com

Mobile: +36 30 448 3561