Senior Manager, Global Regulatory Affairs Vaccines
Site Name: Belgium-Wavre, USA - Maryland - Rockville Posted Date: Sep 15 2021 Are you energized by a highly impactful regulatory affairs role that allows you to shape and accelerate regulatory effectiveness across the organization? If so, this Sr. Manager, Regulatory Affairs, Vaccines role could be an ideal opportunity to explore. The purpose of this role is to: 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/nonclinical (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 specific (clinical/labelling or technical/NC or procedural) section. 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 specific section (clinical/labelling or t/NC or procedural). Provide regulatory input for one (or more, in agreement with his/her manager) 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 a specific section (clinical/labelling or technical/NC or procedural). 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 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. LTT, SRT etc.) and possibly project teams (PTs), for clinical/labelling or technical/CMC or procedural aspects of a given project. Participate to project/product-related discussions and provides in-depth strategic, scientific and RA input, for clinical/labelling or technical/NC or procedural aspects of given project. Provide in-depth input into the asset specific regulatory strategy on a global scale for clinical/labelling or technical/NC or procedural aspects. Provide support to the GRL via critical review of the clinical/labelling or technical/NC or procedural section of regulatory documents, GRPs and KMSs. May fulfil the role of N+1 review as per RSBP for clinical/labelling or technical/NC or procedural-based documents. Provide in-depth input on clinical/labelling or technical/NC or procedural aspects/sections of the Global Regulatory Plan (GRP) Coordinate (for one specific clinical/labelling or technical/NC or procedural part) 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 or technical/NC or procedural sections) 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 or clinical/labelling or use of appropriate regulatory procedures to secure the optimum submission strategy; contribute for clinical/labelling and/or technical/NC and/or procedural aspects. Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/labelling and/or technical/NC and/or procedural aspects May possibly 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, within the remits of his/her expertise area (clinical/labelling and/or technical/NC and/or procedural). 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 or for one of the RA aspects with 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 of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones. Assist other Regulatory Business Operations (RBO) staff in process improvement. Represent RBO in Office of the Chief Regulatory Officer (OCRO) initiatives and process changes. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in a Scientific or related field. 6 or years of industry regulatory affairs experience 2 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 (MS/PhD.) Vaccines experience Ability to coordinate and execute regulatory strategy for a given project/product. Strategic thinker - ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy. Ability to identify and escalate issues to the GRL and to propose mitigation strategies, maximise opportunities, with proven ability to develop collaborative relationships and have high impact and influence Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams. Support the Global Regulatory Lead to ensure regulatory input is provided to other GSK divisions or to regulatory agencies, as appropriate. Good influencing skills Culturally aware. Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner 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: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness *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). 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