Regulatory Project Manager

Nombre del sítio: UK - London - Brentford Fecha de publicación: Aug 3 2022 Regulatory Project Manager An opportunity has arisen to join the Regulatory affairs team. You will be Responsible for the regulatory management of a portfolio of products across the product lifecycle and the primary interface with the local regulatory authorities. Proactive leadership in defining and implementing effective regulatory strategy, influencing as needed to reflect business needs. It’s an exciting time to be joining the team, especially with a new Regulatory Framework in the UK, and this position offers an excellent opportunity to be part of a motivated and collaborative team. Key Responsibilities: Regulatory management (delivery and maintenance) of clinical assets and MAs for a portfolio of products for Ireland and UK. Primary interface with the local regulatory authorities. Ensure product information is compliant with MA. Co-ordinates national input into responses to regulatory questions and regulatory commitments, ensuring alignment with regulatory requirements and strategy. Management of local product registration documents in regulatory databases and repositories. Manage regulatory agency correspondence in accordance with company procedures. Notify to Regulatory agencies product quality and safety issues. Marketing Authorisation Holder (MAH) review of Periodic Quality Reviews. Effective planning of regulatory activities for portfolio. Provides considered regulatory advice, leadership, and expertise to brand teams and to other regulatory and cross functional groups. Co-ordinates meetings with regulatory authorities and plays a key role in these interactions. Builds and maintains effective relationships with (not limited to) internal regulatory, medical, commercial, supply chain and clinical groups. Takes a proactive lead and shows an ability to focus and identify key issues early and contribute fully to the development of solutions. Opportunity to manage non-product activities as needed within the team. Closing Date for Applications: 13th July 2022 (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. 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 234 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. *LI-GSK Why You? Basic Qualifications & Experience: We are looking for professionals with these required skills to achieve our goals: Graduate/PhD level or equivalent in life sciences. Knowledge of drug development process and regulatory affairs. Capable of building and maintaining relationships internally and with regulatory agencies. Ability to work in a complex environment. Good interpersonal, communication and influencing skills. Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience in pharmaceutical industry, including regulatory experience. In depth understanding and practical experience of national or/and EU regulations, guidelines and working practices and of the regulatory issues relevant to the portfolio. Understands the impact of the regulatory environment and proposed changes which are likely to impact the business in the medium term. Can define regulatory strategy. In-depth understanding of regulatory governance, medical and safety. Why GSK? At GSK, we have delivered unprecedented change over the past four years - to improve R&D productivity and performance, transform commercial execution and to strengthen our leadership and reshape our organisation. Now, we’re getting ready to deliver the most significant change to our company in over 20 years. We’re on track to separate and create two ambitious new companies in 2022: A new GSK with a leading portfolio of vaccines, specialty and general medicines, and R&D based on the science of the immune system and genetics; and a new world-leading consumer healthcare company built on brands and innovation and delivering better everyday health. With new ambition comes new purpose. GSK will unite science, talent, and technology to get ahead of disease together. We’ll be a company where outstanding people thrive, delivering strong, sustainable returns to our shareholders and with the power to improve the health of more than 2.5 billion people over the next 10 years. All of this depends on our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; where we are all accountable for our impact and supported to succeed; and where we do the right thing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Commercial: We have a broad portfolio of innovative and established medicines, which generated sales of £17 billion in 2020, that treat everything from COPD to lupus and urology, as well as more than 20 different vaccines, with revenues of over £7 billion, that help protect people at all stages of life in over 160 countries. We are a global leader in respiratory disease and HIV, and we’re developing our presence in specialty therapy areas, including oncology and immuno-inflammation. Our focus is to deliver better and faster for patients globally. Find out more: Annual Report 2020 Product Pipeline Como empresa impulsada por nuestros valores de enfoque al paciente, transparencia, respeto e integridad, sabemos que la inclusión y la diversidad son esenciales para que podamos tener éxito. Queremos que todos nuestros colegas prosperen en GSK, brindando sus experiencias únicas, asegurándonos de que se sientan bien y que sigan creciendo en sus carreras. Como candidato para un papel, queremos que usted se sienta de la misma manera. Creemos en una cultura de trabajo ágil para todos nuestros roles. Si la flexibilidad es importante para usted, lo alentamos a explorar con nuestro equipo de contratación cuáles son las oportunidades. No dude en ponerse en contacto con nosotros si desea analizar cualquier ajuste a nuestro proceso que pueda ayudarlo a demostrar sus fortalezas y capacidades. Puede llamarnos al 0808 234 4391 o enviar un correo electrónico [email protected]. A medida que lo solicite, le pediremos que comparta alguna información personal que sea voluntaria. Esto se utilizará para ayudarnos a comprender qué tan bien estamos haciendo frente a nuestras ambiciones de inclusión y diversidad. Realmente lo agradeceríamos si pudiera tomarse unos momentos para completarlo. Tenga la seguridad de que los gerentes de contratación no tienen acceso a esta información, no se utiliza en ninguna parte del proceso de selección y trataremos su información de forma confidencial y la utilizaremos de forma anónima.