Vaccines Senior Manager, Global Regulatory Affairs

Are you a subject matter expert in technical / CMC and procedural aspects of Global Regulatory Affairs, driven to provide in-depth input into asset specific regulatory strategy on a global scale for clinical/labelling or technical/NC or procedural aspects? Are you driven to provide robust regulatory advice and plans to various project teams and advisory bodies, while ensuring the business needs are in compliance with regulations and/or regulatory advice received from the agencies?

If so, this Vaccines Senior Manager of Global Regulatory Affairs role could be an ideal opportunity to explore.

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) to drive / manage regulatory activities for a project / project within the vaccines team in order to obtain Marketing Authorisation(s) as rapidly as possible, with the best possible label, and to maintain these authorisations.
• Provide input into the content or lead preparation/authoring of relevant technical / CMC project/product specific documents submitted to regulatory agencies worldwide (e.g., MAA/BLA, variations/sBLA, Q&A, scientific consultations, Prior Approval Supplements, etc.) and ensure that these documents meet high scientific standards, regulatory requirements, and project goals.
• Ensure the tracking, delivery and approval of submissions to regulatory agencies worldwide required to establish and maintain Marketing Authorizations, ensuring routine submissions (Annual Reports) and commitments are delivered on time, and strategic submissions are completed in line with project plans.
• Support the Global Regulatory Lead in providing robust regulatory advice and submission plans to the various project teams and advisory bodies to ensure that the project plan is in compliance with global guidance documents, local regulations, and/or regulatory advice received from the agencies.
• Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product, working with internal stakeholders and project, platform, and functional teams to provide support for technical/CMC and procedural aspects of a given project, ensuring alignment.
• Participate in complex project/product-related technical discussions and provide in-depth strategic, scientific and RA input for technical/CMC and procedural aspects of a given project within GRA meetings.
• Participate in platform, project/product, and/or region related discussions as a subject-matter expert regarding technical / CMC and procedural aspects of the project.
• Facilitate and deliver the regulatory strategy to support technical/CMC and procedural aspects of the product lifecycle, ensuring regulatory commitments and routine submissions are tracked and delivered on time.
• Provide input into or lead preparation/authoring of technical / CMC strategy documents (including Key Message Summaries) and/or submissions in collaboration with responsible functional areas, ensuring deliverables are tracked, reviewed, and approved in line with GSK procedures.
• Compile/write high quality project/product specific submissions, in line with the regulatory strategy to obtain and maintain regulatory approval worldwide, ensuring that those documents meet regulatory requirements (procedural and technical) in each region, and are aligned with global strategy.
• Provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of technical / CMC strategy and use of appropriate regulatory procedures to secure the optimum timelines.
• In collaboration with the relevant RA functions, as appropriate, expedite gaps in resources to ensure the execution of the agreed RA plan to the GRL, within the remits of his/her responsibility.
• Be aware of global regulatory guidelines and their impact on regulatory strategy for the particular asset(s), including those for biologics supply.
• Develop and motivate collaborators (within RA team) to achieve quality output, accountability and recognition across the organization and towards the regulatory…