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 Associate Manager -Submission Lead role could be an ideal opportunity to explore.

As Regulatory Associate Manager -Submission Lead, you will be working

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. You will also be responsible to mentors/coaches/trains other team members and reviews work to ensure right first-time submissions.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following…

Key Responsibilities:

• 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 harmonization, 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 required skills to achieve our goals:

• Bachelor’s degree of Pharmacy, OR in a biological, healthcare or scientific discipline.
• Minimum 5 years of pharmaceutical industry experience in a regulatory environment.
• eCTD awareness would be highly preferred to have.
• General understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• General knowledge of Regulatory Affairs responsibilities from pre-IND 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 effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
• Ability to think flexibly in order to meet constantly shifting priorities and timelines.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Export market experience is highly required.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
• Ability to work in a matrix environment, ensure delivery of objectives across cross-functional teams 

Post Closure Date: 22.Aug.2024

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.

Contact information:

You may apply for this position online by selecting the Apply now button.

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