Director, Regulatory Process Management & Governance

Job title:

Director, Regulatory Process Management & Governance

Company

GlaxoSmithKline

Job description

Director, Regulatory Process Management & GovernanceHere 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 webpageIn this role you willMaintain the GRA Written Standards landscape supporting the GRA business activities.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 requirementsDrive a culture of compliance and transparency across the function encompassing a right first-time ethosCoordinate cross-process updates to drive consistency and timely updates to documents, training and communications to the impacted audiencesConsider the user journey of our staff to develop fit for purpose materials to support their roles and internal/external audits including process documents, training, communication and general knowledge managementSupport system releases by ensuring users have access to up to date and accurate support materials to perform their rolesProvide regulatory knowledge and oversight where requiredSupport GRA Process Contacts with risks and issues as they arise, ensuring timely and appropriate plans are in place and visibility of them is provided across the processes to encourage sharing of learnings and to develop cross-process mitigations where possible.Drive a single vision and direction for the team, setting appropriate objectives and timelines for their deliveryManage team resource accordingly and in collaboration with Head, Regulatory Excellence, Process & AnalyticsLead or manage initiatives and projects to support evolving internal and external regulatory requirements impacting GRA processesActively partner with GRA and Global Regulatory Operations (GRO) teams to optimise processes and reduce redundant/non-value activities from the processesLead matrix teams through Process GEMBAs generating outputs aligned to People, Process, Data and TechnologyAct as a key partner in using the regulatory change control procedure and governance to ensure full impact assessment and robust implementation of changeDefine and monitor the necessary metrics to evaluate and improve Regulatory Excellence, Process and Analytics performances in line with GRA and GRO prioritiesWhy 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 proceduresExperience managing procedural documents and associated supporting informationAbility 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/projectsHas 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 wholeHas good project management skills, overseeing and prioritizing multiple activities across one or projects for multiple customersExperience working within a complex IT System Landscape within a regulated environmentTeam/Matrix team leadership experience with the ability to manage and motivate a team/matrix and manage people effectively through changePreferred 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 QualityDocsClosing 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 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 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 and scroll to the Careers Section where you will find answers to multiple questions we receive .As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting site.

Expected salary

Location

United Kingdom

Job date

Thu, 04 Jul 2024 05:57:08 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (hiring-jobs.com) you saw this job posting.