Submission Manager

hace 2 semanas


Xoco, México GSK A tiempo completo

**Site Name**: Mexico City Torre Mitikah**Posted Date**: Feb Are you energized by a highly impactful regulatory affairs role that allows you to shape and accelerate regulatory effectiveness across the organization? If so, this Regulatory Affairs Operations Manager role could be an ideal opportunity to explore.As Regulatory Operations Manager, you will be responsible for leading or supporting strategic and operational Regulatory projects, which support business strategy and platform delivery.This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following- Fulfill standard, ad hoc, or complex data reporting requests and design outputs.- Support Regulatory Business Operations (RBO) in project delivery, process documentation, monitoring, and reporting.- Maintain Team sites and ensure adherence to records retention policies.- Complete necessary training and assist in optimizing project plans (scope, deliverables, resources, timing).- Provide project support to meet business deliverables and assist with process documentation edits.- Analyze and interpret data, identify gaps, and deliver efficient solutions to improve data quality.**_ Why you?_**Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:- Bachelor’s degree.- 3 years of pharmaceutical industry experience in a regulatory environment.- Experience with License Maintenance as well as overall R&D processes.- Direct experience with project planning & execution.Preferred Qualifications:If you have the following characteristics, it would be a plus:- Master’s degree or MBA- Experience working in a matrixed environment- Demonstrated ability to engage and influence senior stakeholders.- **_This is a job description to aide in the job posting, but does not include all job evaluation details._****Why GSK?****Uniting science, technology and talent to get ahead of disease together.**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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).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.**Important notice to Employment businesses/ Agencies



  • Xoco, México GSK A tiempo completo

    **Site Name**: Poznan Grunwaldzka, Bengaluru Luxor North Tower, Egypt - Cairo, Mexico City Torre Mitikah, Mississauga Milverton Drive **Posted Date**: Feb 13 2025 **CTA/IND Project manager-Submission Delivery Excellence-Investigational**,**position holder(s) will be accountable for managing teams of Regulatory Submission Delivery professionals or as...

  • Country Study Manager

    hace 2 semanas


    Xoco, México GSK A tiempo completo

    **Site Name**: Mexico City Torre Mitikah **Posted Date**: Feb 12 2025 **_ Your Responsibilities_**: This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are: - Provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in...