We are looking for an ambitious Manager/Associate Director of Regulatory Affairs to ensure the development of appropriate global and/or regional regulatory life-cycle strategy(s) and their execution for assigned products to meet the needs of the business. This goal has to be achieved whilst ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible life cycle management and expansion commensurate with the available data, and through optimum life cycle maintenance support.
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Accountable to Senior Director of Respiratory Established Products and VP, Global Regulatory Established Products for development of appropriate global and/or regional regulatory life cycle strategy(s) (expansion, management, and maintenance) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work with the GRL and/or Medicine Development Team/Medicine Commercial Team (MDT/MCT), to ensure a robust regulatory strategy is in place to support the regulatory life-cycle strategy and meet the needs of the key markets. Work closely with local / regional commercial team in prioritized countries to deliver the best possible life-cycle management commensurate with available data and in line with the GDS. Lead interactions with local / regional regulatory authorities.
In this role you will
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
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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.
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