Regulatory Associate Manager III-Submission lead

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 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

Job Related Experience -​

• 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.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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