Job Description

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 Affairs Operations Manager role could be an ideal opportunity to explore.

As a Regulatory Operations Manager, you will be responsible for leading or supporting strategic and operational Regulatory projects, which support business strategy and platform delivery.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following\xe2\x80\xa6

• Partner with Regulatory Business Operations (RBO) staff to manage a project (initiate, plan, execute, monitor & control, close)
• Facilitate team meetings.
• Lead sub-teams and lead or manage workstreams within a project.
• Use process improvement tools and approaches to support team effectiveness and delivery.
• Identify obstacles to plan execution and provide contingencies.
• Author new process documentation and ensure appropriate monitoring and reporting are in place.
• Provide interpretation of complex requesting and analyses reporting.
• Determine appropriate process documentation.
• Assist other Regulatory Business Operations (RBO) staff in process improvement.
• Represent RBO in Office of the Chief Regulatory Officer (OCRO) initiatives and process changes.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor\xe2\x80\x99s Degree
• 5 years of industry regulatory affairs experience
• Demonstrated process improvement experience

Preferred Qualifications:

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

• Advanced Degree
• Experience with risk mitigation
• Project Management Professional (PMP) certification
• Six Sigma Training or certification

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making \xe2\x80\x93 using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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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