Regulatory Global Submission Manager

Job Title: Regulatory Global Submission Manager

• In close collaboration with Regulatory Asset Oversight, GRL and RMT, provides project management support at submission level, drives execution of agreed plans and ensures timely and compliant delivery of submissions for US, EU and Rest of the World (ROW) markets.
• Outlines content deliverables, target timelines, submission preparation activities and interdependencies for the various functional lines within the RMT.Performs critical path analysis and scenario planning to evaluate multiple strategies as necessary to achieve accelerated submission timelines.
• Collaborates with publishing and other operational teams to ensure technical compliance and adherence to timelines for preparation and final dispatch of dossiers.
• Maintains submission content plans within Reg Vault and Smartsheet (ISP) for managing major submissions in primary markets and to drive baseline dossiers for the market expansion team in ROW markets.
• Leads submission planning meetings to ensure timely and compliant execution of global submission plans and to identify and quickly remediate any issues or blockers.
• Key contributor to foundation meetings, regulatory matrix team meetings other project-related meetings with ability to influence key aspects of submission strategy, internal processes and submission content.
• Must work collaboratively with staff from other functions and should be capable of working to senior levels in process development functions in provision of advice, interpretation of relevant guidance, researching topics and resolving issues.
• Possess in-depth knowledge of GSK processes, ways of working and provide training, consultation and solutions within the team/ department as well as externally outside the department.
• Independently and confidently executes agreed dossier strategy related to assigned deliverables with minimal input from manager; escalate any issues with business impact and offers potential solutions.
• Ensures alignment and clear understanding of Regulatory Requirement/Legislation/ Guideline for EU, US and ROW markets.
• Must be able to simultaneously manage multiple project assignments of varying complexity.
• May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
• Support peers and identify improvement opportunities for Regulatory processes, policies and systems.

Minimum Level of Job-Related Experience required

• Demonstrated experience in submission management planning for major pharmaceutical and/or vaccine assets as an integral member of Regulatory project teams.
• Knowledge in Regulatory Affairs covering a breadth of global regulatory procedures, particularly those related to NCE/NBE and major line extensions.
• Must be proficient with regulatory submission management concepts and the connections between various regulatory systems and associated processes.
• Demonstrated proficiency with submission planning tools (Smartsheet, MS Project), Regulatory systems and related reporting software.
• Ability to effectively interact through different levels in the regulatory organization and with stakeholders outside of regulatory with ability to persuade and influence others in achieving team objectives.
• Must be able to work with minimal supervision in a complex organization driving the delivery of key departmental objectives.
• Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
• Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience.
• Ability to build effective working relationships and work in a matrix environment effectively.
• Demonstrated ability to think flexibly to meet constantly shifting priorities and timelines.
• Demonstrated ability to proactively manage workload, timelines and identify priorities. Build relationships with relevant internal functions.
• Proven ability to work on multiple projects simultaneously.