Regulatory Specialist - Ciudad de México - GSK

GSK

Empresa verificada

Ciudad de México

hace 2 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

Site Name:
Mexico City Torre Mitikah

Posted Date:
Aug

**_

Your Responsibilities_**:
This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are

Author and compile Regional/Country PI as per regulatory authority labelling requirements and GSK process and standards.
Author and compile marketspecific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards.
Provide support to global and local GRA team members through preparation of other labelling documents as required
Complete quality and consistency checks of labelling document content.
Efficiently coordinate and manage labelling documentation and data in regulatory systems.
Provide advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams.
Effectively communicate with GSK staff to author, compile and deliver quality labelling documents. May communicate with Regulatory Agencies and third parties on behalf of GRA labelling staff.
Support other regulatory functions and participate in other projects and activities as needed, such as leading the design and implementation of changes to labelling processes and evaluation of new agency labelling requirements.
For some roles, may be required to perform translation of labelling text into identified languages.
Subject Matter Expert in country/regional labelling content and process for markets with complex labelling requirements

_ Why you? _

_Basic Qualifications:
_ We are looking for professionals with these characteristics to achieve our goals:

University Degree in a biological, healthcare, or scientific discipline.
4+ years of experience In Regulatory Labelling processes in the Pharmaceutical Industry
Advanced English Level.

_ Preferred Qualifications:
_However, if you have the following, it would be a plus:

Veeva Vault experience.
Regional or Global regulatory experience

_ Why GSK? _

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.

A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Find out more:

Annual Report 2021

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

**Important notice to Employment businesses/ Agencies