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Reference #: 402953 Site Name: USA - Maryland - Rockville, Cambridge Park Drive, Upper Providence Posted Date: Aug 27 2024

Director, Global Regulatory Affairs - RNA vaccines

Are 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 requi ed 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 A preferred candidate would show strengths in the following areas: Strategic Leadership - Experience in providing strategic advice on integrated regulatory development plans and life cycle management, preferably for the US. Providing US-focused input into regulatory strategy, evaluating potential impact on overall project/product strategy. Leveraging internal and external regulatory and scientific networks to problem solve. Providing input into corporate regulatory positioning including US key considerations early in the product development. Writing/critically reviewing, while ensuring rigorous scientific content/quality/compliance, key documents targeting internal or external key audiences, including but not limited to initial IND and related amendments, annual reports, status reports on post marketing requirements/commitments related to clinical safety, clinical efficacy, or clinical pharmacology, briefing documents, key meeting summaries, and BLA modules. People & Program Management - Identifying and escalating regulatory or programmatic issues while proposing mitigations strategies and solutions/problem solving. Developing plans and timelines for complex projects and collaborating with other departments and teams in the delivery of outputs in a timely manner. Forming collaborative relationships and having high impact and influence on multicultural, diverse, and/or international teams. Ensuring that a corporate or departmental regulatory voice is clearly articulated and heard consistently and concisely in various cross functional teams. Enterprise thinking - Understand the constraints and drivers of other functions and the potential impact on regulatory affairs World-wide, including how regulatory affairs may facilitate in achieving the overall corporate goal. Proactive leadership - Identify issues and maximize opportunities. Quickly assimilate facts and data and develop an understanding of complex matters with the ability to translate this understanding to internal stakeholders (regulatory and non-regulatory experts).

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK? Uniting science, technology and talent to get ahead of disease together.

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).

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