Site Name: USA - Maryland - Rockville Posted Date: Jan 5 2022 Other US locations may be considered Are you interested in a highly visible leadership role that allows you to lead a key development project at GSK while being part of a dynamic multicultural team focusing on people development- and using innovative approaches? If so, this Director, Global Regulatory Affairs role is an exciting move to explore. The role: • Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for new vaccines as rapidly as possible, with the best possible label, and to maintain these authorisations. • Determine from a strategic and scientific perspective the content of regulatory documents submitted to FDA (eg. BLA, sBLA, Q&A, scientific consultations, PSP, INDs, etc.) and ensure that these documents meet high scientific standards and regulatory requirements. • Lead multidisciplinary forum, compile/write/review high quality project/product specific regulatory documents to be submitted to FDA (for clinical/labelling, CMC/NC and/or procedural) and ensure that those documents meet regulatory requirements. • Provide support in compiling/writing US relevant sections of briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, etc.). • Provide US strategic regulatory input for all development stages of the project/product within a given product portfolio to key stakeholders (e.g., provide advertising and promotional expertise to US commercial team). • Cover project-specific responsibilities within a given portfolio, and serve as line reviewer for US submissions to ensure adequacy and optimization where possible of US specific aspects • Participate in project/product-related discussions and provide strategic, scientific and regulatory input, for FDA specific aspects of given project topline and in depth on clinical/labeling, CMC/NC, advertising and promotion and/or procedural aspects. • Serve as the point of contact for FDA for specific products and development programs. Ensure professional and collegial relationship, applying best practices for each program assigned. • Provide input to Vaccines Development Plans in order to optimize the US label and secure proper alignment of CMC/NC and/or clinical/labelling. Assure use of appropriate regulatory procedures to secure the optimum submission strategy and achievement of US commercial promotional goals. • Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; accountable for execution for US clinical/labelling, CMC/NC and/or procedural RA aspects. • Stay current with changes in regulatory guidelines and rules, understand and communicate their impact on regulatory strategy for the particular asset(s); advise project teams on how best to address changes. • Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the FDA. • Ensure planning and proper organization of US activities in line with the overall project plan and RA milestones; Raising risks (such as gaps in resource or project related) for resolution within global teams. • Support the Global Regulatory Lead in providing robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agencies. • May act as lead or N+1 within the project, being accountable for the overall delivery of project-related activities, in collaboration with the members of the team. Why You? Basic Qualifications: Bachelors' degree in chemistry, biology, biochemistry, or similarly applicable discipline. Solid industry regulatory affairs experience. Experience in scientific and regulatory in all stages of product development. Experience in clinical regulatory affairs as well as CMC regulatory affairs for pre-licensed and licensed biologic product or vaccine. Knowledge in IND and NDA/BLA regulations and US regulations pertinent to product development and licensure. Knowledge of scientific basis for clinical development, endpoints, and product CMC is critical to role. Experience as liaison with US FDA. Preferred Qualifications: Advanced degree. Experience at a large pharmaceutical/vaccines company. Experience in providing US-focused input into regulatory strategy and strategic advice on integrated regulatory development plans and life cycle management. People & Program Management skills and experience. Understanding of the constraints and drivers of other corporate functions and the potential impact on regulatory affairs World-wide. Ability to Identify issues, maximize opportunities, develop an understanding of complex matters and report it to internal stakeholders (regulatory and non-regulatory experts). Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LIGSK *VxRD If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. 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