Reg Submission Lead III, SDE - Pipeline

Job description

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary Submission Delivery Excellence (SDE) is a Regulatory Affairs function which brings together the planning, operation and execution aspects for key regulatory deliverables such as new chemical entities, product expansion dossiers, labeling outputs, license maintenance and lifecycle management dossiers and regulatory information management. This position will reside in the Pipeline group which is accountable for planning, production and submittal of Regulatory dossiers to GSK’s primary markets to support registration of new medicines in line with R&D objectives for marketed products and line extensions of regulatory licenses worldwide. In this role, the position holder will be responsible for coordinating major and lifecycle regulatory submissions in our market expansion regions, managing and tracking project timelines, communicating with regulatory and operational staff across various functions, maintaining submission workplans and up-to-date knowledge of global regulations and guidelines to support internal stakeholders. The position holder will work closely with the GRL/Regional Rep (TG)/EU Agent/LOC (or equivalent) and functional teams to coordinate the appropriate content for specific submission packages within the Regulatory Vault system, maintain an accurate and current project plan and drive team members to deliver compliant submission dossiers to accelerated timelines. The job holder will support R&D projects ensuring submissions are delivered to agreed timeframes and in compliance with GSK process and policy as they apply to the role. The job holder will serve as a mentor and trainer for those team members to ensure they are delivering on their assigned projects and meeting personal and department objectives. A clear understanding of Regulatory requirements/guidelines & GSK processes/ways of working is required to be able to consult and advise team members within various contributing functions within a Regulatory matrix environment. Responsibilities Accountable to Project Lead or GRL/ Regional Rep/ EU Agent / C&EP TG /LOC or equivalent with input from Functional teams (CMC/Clinical/nonclinical) for delivery of assigned submissions to agreed timeframes and appropriate content independently and confidently for EU, US and Rest of the World (ROW) market. Responsible for coordinating the market expansion activities associated submissions for new registrations and line extensions including the initial NDA/MAAs, type 2 variations/supplements, pediatric submissions and responses to HAQs. Works with staff from other functions and should be capable of working to senior levels in process development functions in provision of advice, interpretation of relevant guidances, researching topics and resolving issues. Possess in-depth knowledge of GSK processes, ways of working and provide training, consultation and solutions within the team/ department as well as externally outside the department. Independently and confidently executes agreed dossier strategy related to assigned deliverables with minimal input from manager; escalate any issues with business impact and offers potential solution. Ensure alignment and clear understanding of Regulatory Requirement/Legislation/ Guideline for EU, US and ROW markets, including Market Specific Requirements. Proficiently use intelligence resources to determine MSR data package requirements and ensure they are fit for purpose. Simultaneously manage multiple project assignments of varying complexity. May be required to perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines. May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities. Serve as a reviewer for peers and identifies improvement opportunities for Regulatory processes, policies and systems. May be required to lead or participate in process improvement initiatives Preferred Qualification Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines Chemistry, pharmacy or other related science or technical bachelor’s degree. Masters degree or higher in biological or healthcare science Regulatory, Pharmaceutics, or other related science or regulatory affairs. Project Management, Communication Minimum Level of Job-Related Experience required Proven Pharmaceutical experience commensurate with requirements of the position. Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. Understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical and vaccines products. Demonstrated proficiency with RIM systems to efficiently meet submission deliverable objectives while ensuring compliance. Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines. Excellent written and verbal communication skills and ability to present information in a clear and concise manner. Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience. Ability to build effective working relationships and work in a matrix environment effectively. Ability to think flexibly to meet constantly shifting priorities and timelines. Demonstrated ability to proactively manage workload, timelines and identify priorities. Build relationships with relevant internal functions. Proven ability to work on multiple projects simultaneously. How to apply If this role excites you and you want to grow your regulatory career while making a meaningful impact, we want to hear from you. Please apply and tell us how your experience matches this role. If you need adjustments during the recruitment process, let our recruitment team know so we can support you. Skills Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Inclusion at GSK: As an employer committed to Inclusion, we encourage you to reach out if you need any adjust