Senior Manager, Global Regulatory Affairs (RNA Vaccines)
Site Name: USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence Posted Date: Aug 24 2021 Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Senior Manager, Global Regulatory Affairs (RNA Vaccines) could be an ideal opportunity to explore. As a Senior Manager, Global Regulatory Affairs (RNA Vaccines), you will be responsible for regulatory submissions, interactions, and strategy related to products within the US and abroad. Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorisations. Determine from a strategic and scientific perspective the content of relevant sections (technical/non-clinical (NC), clinical/labelling or procedural) of project/product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations, Paediatric Investigational Plans, etc.) and ensure that these documents meet high scientific standards and regulatory requirements. Responsible for one or more specific (clinical/labelling and/or procedural) section(s). Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, KMS, etc.). Responsible for one or more specific sections (clinical/labelling and/or procedural). Provide regulatory input for one or more specific sections of certain/all development stages of the project/product within a given product portfolio. Ensure, from an RA perspective, the execution of the product development regulatory strategy in order to ensure a complete and rapid development of the asset, for one or more sections (clinical/labelling and/or technical/NC and/or procedural) This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product. Interact with (or represents his/her area/product at) internal project related teams (e.g. GPLT, TDT, , SRT etc.) and possibly project teams (e.g. VDT, PTs), for all parts of RA aspects of a given project top line and in depth on clinical/labelling or technical/NC or procedural aspects. Participate to project/product-related discussions and provides strategic, scientific and RA input, for all parts of RA aspects of given project topline and in depth on clinical/labelling or technical or procedural aspects. Provide input into the asset specific regulatory strategy on a global scale. Provide support to the GRL via critical review of one or more specific sections (clinical/labelling and/or technical/NC and/or procedural) of regulatory documents, GRPs and KMSs. May fulfil the role of N+1 review as per RSBP. Provide input into the Global Regulatory Plan (GRP) for one or more specific (clinical/labelling and/or technical/NC and/or procedural) sections Coordinate (for one or more specific (clinical/labelling and/or technical/NC and/or procedural) sections) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL For cross-product sections or stand-alone documents work with the function to ensure content is aligned with targeted overall profile of the product. Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for clinical/labelling and/or technical/NC and/or procedural) and ensure that those documents meet regulatory requirements. Provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of technical/NC, clinical/labelling and use of appropriate regulatory procedures to secure the optimum submission strategy; contributes for clinical/labelling and/or technical/NC and/or procedural and accountable for one of the RA aspects. Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/labelling and technical/NC and procedural and accountable for one or several of the RA aspects. May act as the point of contact for Regulatory Agencies for asset(s) (project-specific) Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of GSK Vaccines submissions for the asset(s). In collaboration with the relevant RA functions, as appropriate, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL. Must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s). Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities. Ensure planning and proper organisation of activities (for one or more of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in life sciences or related (Biology, Chemistry) Six or more years of experience in regulatory affairs. Two or more years experience in managing teams and leading in a matrix organization. Two or more years experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred. Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline. Experience at a large global pharmaceutical or vaccines company Experience leading global teams RNA Vaccines experience Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *This is a job description to aide in the job posting, but does not include all job evaluation details. *LI-GSK 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. 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