Basic Qualification:10 - 15 Years of professional experience.Experience in Regulatory life Cycle till Phase 4.Location - Bangalore.Would you like to drive change and transformation efforts that enable successful regulatory outcomes for GSK? If so, this Manager, Regulatory Asset Oversight role could be an ideal opportunity to explore.As Manager, Regulatory Asset Oversight, you will manage multiple projects and teams simultaneously and will provide assessments (metrics, data) and conclusions/action plans within and across departments. You’ll identify risks associated with submission data and information packages, and lead in the creation, maintenance and continuous improvement of Regulatory processes, policies and systems.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following
- In close collaboration with the GRL and RMT, develop and maintain a holistic view of the global regulatory integrated plan at the asset level for operationalizing the Global Regulatory Strategy and supporting the GRL in ensuring appropriate resource is engaged to deliver to the plan.
- Drive the execution of the agreed plans to ensure team is on-track to deliver per the Global Regulatory Strategy (GRS), performing scenario planning, impact analyses, critical path analyses and facilitate risk mitigation in response to any issues/risks that arise.
- Leverage expertise to assist RMTs and GRLs with submission delivery strategies that align with R&D objectives, e.g. Hyper-Acceleration, Acceleration in regions.
- Employing a structured approach with assigned RMTs to ensure that the submission delivery strategy is aligned with the Global Submission Strategy (GSS) throughout the late-stage Development lifecycle.
- Proactively partner as a Single Point of Contact with RMTs and Submission Delivery Excellence colleagues to identify and remove barriers that will prevent a successful outcome on defined filing strategies.
- Coordinate the RMT Meeting and other Cross-Functional, Regulatory-Owned Engagements for success ensuring logistics, agenda topics and meeting materials are available and organized for the use of the team.
- Proactively identify upcoming activities or milestones which might impact regulatory deliverables and escalates of issues and blockers to Sr. Manager, Regulatory Asset Oversight, and leadership as required.
- Utilizes Regulatory technologies to provide real-time, accurate submission status information (visuals and reports) for RMTs to highlight compliance from central dispatches through to registrations across markets. Contributes to Regulatory Asset Oversight function metrics and KPIs.
- Leverages data from RIM systems to support RMT needs, ensuring its accurate, complete, and fit for purpose.
- Facilitate discussions with LOCs and RMTs as needed to ensure aligned submission delivery strategy and efficient lifecycle filing strategies from lead markets through to regional expansion.
- May serve as SME inputting to Wows in conjunction with Stakeholders with a focus on continuous improvement, identification and implementation of automation opportunities, and compliance with Regulatory authority requirements.
Why you?Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:- Bachelor’s Degree
- Extensive knowledge of drug development and manufacturing and supply processes.
- Broad and deep knowledge of worldwide regulatory requirements.
- Successfully managed multiple projects
Preferred Qualifications:If you have the following characteristics, it would be a plus:
- Degree in Chemistry, pharmacy or closely related science
- Demonstrated professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
- Broad knowledge base across regulatory functions.
- Experience in influencing and negotiating with GSK personnel as well as external partners in a variety of settings.
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, rigor and risk.
- Managing 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.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, it’s 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.
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