Director, Regulatory Process Management & Governance

Here at GSK we are looking for a regulatory professional to lead, develop and implement change. This person will engage with a wide range of stakeholders across the business and be a key contributor to the programs which are seen to be priority. We are looking for someone who comes with experience in regulatory filings and has a passion for process improvement and governance.

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

In this role you will

• Ensure the process management and governance framework is upheld and executed in accordance with expectations.

• Where required, perform the Global Process Owner (GPO) role for a GRA owned process and execute in accordance with GPO role requirements

• Drive a culture of compliance and transparency across the function encompassing a right first-time ethos

• Lead or manage initiatives and projects to support evolving internal and external regulatory requirements impacting GRA processes

• Actively partner with GRA and Global Regulatory Operations (GRO) teams to optimise processes and reduce redundant/non-value activities from the processes

• Lead matrix teams through Process GEMBAs generating outputs aligned to People, Process, Data and Technology

Why you?

Basic Qualifications & Skills:

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

• Experience managing procedural documents and associated supporting information

• Ability to operate with independence and 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 organization to be able to offer maximum benefit to our users and GSK as a whole

• Has good project management skills, overseeing and prioritizing multiple activities across one or projects for multiple customers

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

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Experience working in Veeva Vault QualityDocs

Closing Date for Applications – 16th July 2024 (COB)

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?

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 ma