Regulatory Global Process Owner
 

Location: GSK HQ, London

The Regulatory Global Process Owner (GPO) are deep subject matter experts accountable for the development, maintenance and monitoring of Regulatory processes in accordance with the necessary regulatory requirements and industry standards, ensuring audit and inspection readiness.

They will drive a focus of process design and continuous improvement, creating value by ensuring our processes are meeting the business and regulatory need, are fit for purpose for our users and are supported by technology to improve efficiencies and enable accelerated delivery of our medicines and vaccines to our patients.
 

Key Responsibilities include, but are not limited to:

• Develop and maintain GRA owned processes, their strategic direction and continuous improvement

• Ensure that assigned processes are compliant with global legal/regulatory requirements and industry standards; actively monitor compliance with existing or newly initiated processes across products and regions.

• Design and implement key performance indicators (KPI) to monitor performance of improved processes and measure results; collaborate with Regulatory peers, Senior leaders and Quality Leads to develop in-process controls and management monitoring strategies for assigned processes.

• Lead/input to Risk and Issue Management activities, designing/agreeing appropriate mitigations

• Lead & enable process improvement initiatives, drive innovation in continuous improvement programs to deliver streamlined, efficient processes

• Maintain current knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence and industry standards pertaining to the assigned processes

• Be accountable for maintaining personal readiness in response to internal audit or regulatory inspection and provide expert advice on responses to audit observations; be point of contact and interact with inspectors to support audits as appropriate

• Build a strong network of stakeholders and SMEs across GSK to support and influence cross functionally.  Providing oversight and direction to any matrix assigned Regulatory Process Leads as required 

Why you? 

Basic Qualifications:

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

• Has extensive experience of Pharmaceutical Regulatory Affairs covering a breadth of global regulatory procedures, including applicable Regulatory requirements

• Ability to operate with independence effectively communicating at all levels within GSK and within or leading a team to ensure on-time delivery of objectives/projects

• Has an end-to-end enterprise mindset with the ability to break down silo’s within and across the organisation to be able to offer maximum benefit to our users and GSK as a whole

• Experience working within a complex IT System Landscape within a regulated environment.

• Team/Matrix team leadership experience with the ability to manage and motivate people effectively through change.

Preferred Qualifications:

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

• A proven capability as a leader with a global mindset

• A flexible approach, readily adapting to changing circumstances and new opportunities; encourages, leads and drives change where appropriate.  Challenges and questions ways of working to seek improved processes.

• Establishes team goals and uses these to seek improved performance; sets challenging but realistic targets.

• Able to think creatively to source information relating to role and the interaction with the broader regulatory function.

• Excellent communication skills both oral and written.  Proven ability to communicate with clarity, impact and passion.

• Proven track record in promoting and delivering innovation

• Proven ability to build high-performing global matrix team relationships

• A strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way.

Closing Date for Applications: 7th October 2024 (COB)

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

Why GSK? 

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery.  We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.

Find out more:

Our approach to R&D.   
 

Why GSK?

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

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. 

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive

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