Job Description

Key Responsibilities :

• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• A good understanding of Clinical Trial Directive, DIA TMF Reference Model and CTA/IND submission requirements for multiple countries/submission types
• Responsible for: coordination, development, refinement of the CTA/IND lifecycle strategy, timely content & delivery appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures.
• Accountable to the CTA Team Manager for overall work plans, accountable to individual GRLs/TGs for study submission planning & delivery status.
• Accountability for agreed tasks and projects.
• Ensure independent communication, with a range of internal GSK staff, in supporting achievement of the assigned goals.
• Ensure quality of both own and submission team\xe2\x80\x99s work, delivering to agreed timeframes, including compliance with GSK systems and record keeping.
• Provide input to internal processes and written standards.
• To work flexibly to meet constant shifting priorities and timelines
• May provide support to other activities within the CTA/IND and/or Content Delivery Team.

Educational Background

Bachelor\xe2\x80\x99s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment

Job-Related Experience

• 5-8 years of relevant experience
• Role requires a general understanding of CTA/IND submission requirements for multiple countries/ submission types and an ability to work in a matrix environment.

Other Job-Related Skills/Background

\xc2\xb7 Knowledge of practical implementation of the European Clinical Trial Directive.

\xc2\xb7 Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.

\xc2\xb7 A good understanding of Clinical Trial Directive and CTA/IND submission requirements for multiple countries/submission types

\xc2\xb7 Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines

\xc2\xb7 Excellent written and verbal communication skills and ability to present information in a clear and concise manner

\xc2\xb7 Ability to interpret and advise on guidelines and requirements on a global basis

\xc2\xb7 Ability to build effective working relationships and work in a matrix environment effectively

\xc2\xb7 Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.

\xc2\xb7 Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.

Ability to think flexibly to meet constantly shifting priorities and timelines.

Why Us?

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 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.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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