Job Description

Basic Qualifications: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 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.Direct line management responsibilities for 2-4 staff from market expansion teams to oversee project assignments, train on advanced project management concepts and mentor career development.Preferred Qualifications: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.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 riskManaging 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.Inclusion at GSK:As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.Please contact our Recruitment Team at to discuss your needs.Why GSK?Uniting science, technology and talent to get ahead of disease together.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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in gsk.com, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.

GlaxoSmithKline