GlaxoSmithKline
Director, Global Regulatory Affairs (RNA Vaccines)
GlaxoSmithKline, Cambridge, Maryland, United States, 21613
Site Name:
USA - Maryland - Rockville, Cambridge Park Drive, Upper ProvidencePosted Date:
Aug 27 2024Director, Global Regulatory Affairs – RNA vaccinesAre you interested in a highly-visible Global regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this
Director, Global Regulatory Affairs (RNA Vaccines)
could be an ideal opportunity to explore. This role will focus on the development of mRNA based vaccines within GSK.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: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:We are looking for professionals with these required skills to achieve our goals:Bachelors degree & 10 plus years in regulatory affairs OR Advanced Degree & 5 plus years.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.Experience as liaison with US FDA.Preferred Qualifications:If you have the following characteristics, it would be a plus:Experience at a large pharmaceutical/vaccines company.Excellent Communication Skills.Experience working successfully in a matrix environment.Strong leadership skills.Why GSK?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.
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USA - Maryland - Rockville, Cambridge Park Drive, Upper ProvidencePosted Date:
Aug 27 2024Director, Global Regulatory Affairs – RNA vaccinesAre you interested in a highly-visible Global regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this
Director, Global Regulatory Affairs (RNA Vaccines)
could be an ideal opportunity to explore. This role will focus on the development of mRNA based vaccines within GSK.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: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:We are looking for professionals with these required skills to achieve our goals:Bachelors degree & 10 plus years in regulatory affairs OR Advanced Degree & 5 plus years.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.Experience as liaison with US FDA.Preferred Qualifications:If you have the following characteristics, it would be a plus:Experience at a large pharmaceutical/vaccines company.Excellent Communication Skills.Experience working successfully in a matrix environment.Strong leadership skills.Why GSK?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.
#J-18808-Ljbffr