The Regulatory Specialist will play a key role in submissions to ensure the successful delivery of an overall regulatory plan. The specialist will lead interactions with the LOC’s and central teams, ensuring regulatory plans are able to meet the business goals. The role will be exposed to a variety of regulatory activities and, in time, will be given the opportunity to take on more strategic regulatory responsibilities as the role grows alongside personal capability and potential.

Key Responsibilities

· Responsibility for the leadership of, preparation, and review of day to day regulatory submissions with full accountability for delivery

· Accountability for larger submissions as part of an overall project plan i.e. initial submissions and responses to questions

· Working with the Global Regulatory Lead/Regional representative/Team Manager, to develop a regulatory strategy

· Ensuring quality of both own and teamwork and compliance with regulatory guidelines and process within the required timelines

· Liaising with Regulatory Agencies to resolve straightforward issues in relation to their accountabilities

· Implementation of the submission strategy

· Responsible for the maintenance activities associated with an Approved product / Investigational products

Requirements

· 3+ years of relevant experience in regulatory affairs including the leadership and delivery of a range of regulatory submissions

· Bachelor’s Degree in pharmacy or biological or chemical science

· Knowledge of regulatory agency guidelines and expectations in the submission process

· Experience in the regulatory agency review process

*LI-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.​

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