Senior Manager, Global Regulatory Affairs

Site Name: Italy - Siena Posted Date: Feb 8 2023 Senior Manager, Global Regulatory Affairs Position holder (PH) will have global responsibility (for Regulatory Affairs) of given activities for a Project/Product within GSK Vaccines. In this role you will… Provide input to/manage regulatory activities in order to obtain Marketing Authorizations for early development products as rapidly as possible, with the best possible label, and to maintain these authorizations. Determine from a strategic and scientific perspective the content of relevant sections (clinical/labelling or procedural) of project/product specific documents submitted to regulatory agencies worldwide (eg. CTA/IND, Q&A, scientific consultations, Paediatric Investigational Plans, PSP, 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 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. 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. Key Responsibilities: The role includes the following responsibilities: 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. CRT, SRT etc.) and possibly project teams (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 procedural) sections Coordinate (for one or more specific (clinical/labelling 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 procedural) and ensure that those documents meet regulatory requirements. Provide input to Vaccines Development Plans in order to optimize 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. 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 organization 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? Qualifications & Skills: • Advanced Scientific Degree (General Science or Life Science Degree) • Senior Global Regulatory Manager: 6+ years significant experience in regulatory affairs, or appropriate relevant experience • Broad knowledge is required and covers scientific as well as regulatory expertise • Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred. Preferred Qualifications & Skills: Ph.D or M.D (Pharmacy, Chemistry, Biology or Medicine) 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, maximize 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 Ability to resolve problems through resourceful use of information and contacts. Enterprise thinking – needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal. Inclusion & Diversity at GSK: Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career. GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant. We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team (contact email) to further discuss this today. We will request equal opportunities information from you and whilst disclosure is optional, we encourage you to be open, enabling us to monitor the inclusivity of our recruitment practices for the benefit of everyone. Your data will remain confidential, is never shared with our Hiring Managers and never affects the status of your application. 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. 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