Regulatory Affairs Specialist - Lisboa, Portugal - GSK

GSK

Empresa verificada

Lisboa, Portugal

há 1 semana

Postado por:

João Santos

Recrutador de beBee

Descrição

Site Name:
Lisbon

Posted Date:
Apr 8 2024

We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included.

We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage _Life at GSK | GSK_

Job Purpose

Obtaining marketing authorization approval and lifecycle management of products under its responsibility ensuring compliance with national/European legislation and internal SOPs/WoWs
Backup of local responsible for Artwork Management using Harmony & GLAMS systems: coordination of packaging materials, new product introduction (NPI, new presentation pack, new indication, new line extension) with the objective of assuring its continuos update, in compliance with the legislation and local procedures to maintain continuous supply.

In this role, you will...

Management of submission and followup of MAA requests, variations, renewals and MAH transfers until regulatory approval with National Authority for products under its responsibility
Share with local stakeholders' regulatory timelines on new products/line extensions in pipeline/product already approved, including relevant regulatory information regarding competitors and submission and management of abbreviated risk minimization measures with local Authority (when applicable)
Support and coordination with local Co-Promoted 3rd party ensuring regulatory compliance and ensure updating of Regulatory Information Management System/KPI input when required.
Backup of local responsible for

Artwork Management:

responsible for the preparation and sending of the due documentation for the NPI, New Packs, Line Extensions, updates of current MA for the creation of new packaging components for marketed products.

Coordination of the new artwork proofs between Regional Service Center or local Agency and the local RA team and Supply Chain, to comply with the regulatory requirements (local and GSK) for their implementation

Review and approval of packaging materials to confirm they are in compliance with the current legislation/internal SOPs & WoWs
Management of payment of regulatory fees to National Authority. Management and coordination of CPP requests and Participation on the training plan for new RA Trainees

_ Why you?_

Basic Requirements
We are looking for professionals with these required skills to achieve our goals:

Minimum Level of Education: Degree/Master's degree
Area of Specialisation: Pharmaceutical Sciences
Experience in Regulatory Affairs Area
High level of English

Preferred Requirements:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

Ability to work in a team
Sense of responsibility
Good knowledge of information technology as user

Job Posting End Date: 22/04/2024_

Why Us?

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 organization where people can thrive.

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.

GSK is an Equal Opportunity/Affirmative Action Employer.

All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.

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