Sr Submission Coordinator

Site Name:
Mexico City Torre Mitikah

Posted Date:
May

This role works closely with the Global Regulatory Lead (GRL), Regulatory Matrix Team (RMT), global submission teams and Local Operating Company regulatory contacts to deliver submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices.

_ Your Responsibilities:
_This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are:

• Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices
• May be responsible for leadership of relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals, site registrations/renewals/variations, label harmonisation, periodic benefit risk evaluation reports (PBRER) submissions etc)
• May be required to perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines.
• May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
• May be the primary contact for the GRL, maintaining the overall RMT workplan (including relevant regulatory milestones according to the phase of development)
• May be required to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets.
• May be required to lead or participate to process improvement initiatives.

_ Why you? _

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

• Degree in a biological, healthcare, or scientific discipline
• 5+ years of experience in Regulatory Affairs
• Advanced English level
• General understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
• General knowledge of Regulatory Affairs responsibilities from preIND through Phases I-IV
• Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
• Ability to work in a matrix environment, ensure delivery of objectives across crossfunctional teams.
• Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.

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

• Project Management courses or experience
• Veeva Vault
• International Regulatory Affairs Knowledge

_ 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.

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.

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

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