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Reference #: 405165 Site Name: Durham Blackwell Street, USA - Pennsylvania - Upper Providence Posted Date: Sep 25 2024

Manager- Specialty Care, Global Regulatory Affairs

Job Description

Ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile.  This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labelling to meet the Medicine Profile, commensurate with the available data.

Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans.  In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency.  Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile. Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data.  Lead interactions with local / regional regulatory authorities.

Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally. Implement the regional strategy(s) in support of the project globally Lead regulatory interactions and the review processes in local region Ensure appropriate interaction with global/regional counterparts and commercial teams in local region Ensure compliance with global/ regional requirements at all stages of product life Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset

Why you?

Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:

Bachelor's degree in Biological or Healthcare Science Experience of all phases of the drug development process in regulatory affairs preferred Experience in leading regional development, submission and approval activities in local region(s) Knowledge of clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

Leadership Ability to foster strong matrix working. Facilitates dialogue between team and matrix members to contribute their ideas. Capable of developing and recommending strategies for change. Shows a constant focus on improving performance and excellence in all tasks.  Challenges and questions ways of working to seek improved process.  Seeks to raise levels of performance by establishing or improving process

Business Skills Knowledge of relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine Good communication skills, especially in writing.  Capable of delivering key communications with clarity, impact and passion Ideally good listening and comprehension skills; proactive in identifying potential issues and escalating them accordingly Capable of identifying project or team issues in advance and seeking necessary help and support to resolve. Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.  Recognises potential long term issues for projects. Ability to tak sound decisions and in doing so, the job holder will use a range of sources and weight benefits and risks before making important decisions. Developing personal networks, within GSK and capable of using them to secure appropriate support and outcome for a project. Proficient in digital fluency capabilities to enhance project delivery and drive efficiency and innovation.

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 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.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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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