Regulatory Executive (1 Year Fixed Term Contract) Brentford, United Kingdom Regulatory 278385 Site Name: UK - London - BrentfordPosted Date: Feb 5 2021Regulatory Executive (1 year Fixed Term Contract)GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.As a Regulatory Executive you will be supporting activities required to implement Brexit across the UK and Ireland for Rx, Vx and devices. You will also be defining Project Plan for LOC Brexit related submission and artwork activities, including actions required for NI protocol. You will be Project Managing the delivery of LOC Brexit submission and artwork activities according to defined plan along with working with stakeholders and key functions to align support. In this position you will also be identifying, resolving issues and streamlining ways of working to effectively to deliver and providing operational support to deliver identified submissions.Key Responsibilities include, but are not limited to:Build LOC specific Plan(s) of required activities and submission timelines (CAP conversion, pack changes, NI protocol, other UK licence changes)Work with stakeholders across LOC, manufacturing sites, artwork hubs and Global Regulatory Functions (Rx and Vx) to ensure timely delivery of artwork and submissionsDefine Ways of working with supporting functions to ensure efficient and consistent delivery of dossiers.Identify issues requiring resolution and escalate/ resolve appropriatelyProvide support to product related submission and artwork activity in relation to Brexit activities as requiredProvide regular Communication of activities and statusBuilds and maintains effective relationships with (not limited to) internal regulatory, artwork studios, manufacturing sites, medical, commercial, supply chain and clinical groups.Work with SMEs to identify updates to existing processes may be requiredManage regulatory agency correspondence in accordance with company proceduresResponsible for the local management of product registration documents in regulatory databases and repositories.Use of internal systems for planning and prioritization (Regulatory and Artwork systems)Provide support with artwork initiation activities and associated used of systems where requiredClosing Date for Applications: Friday 19th February 2021Please take a copy of the , 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.During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. *LI-GSKWhy you?We are looking for professionals with these required skills to achieve our goals:Basic /Preferred Qualifications:If you have the following characteristics, it would be a plus:Life Sciences Graduate/PhD level or equivalent, preferable experience in the pharmaceutical industry.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 – 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.At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it’s about you being motivated to do your best work, in a place where you can be you, feel good and keep growing. Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.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 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.Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email [email protected]
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