Reference #: 374603Site Name: UK - London - Brentford, Belgium-Wavre, Durham Blackwell Street, Upper ProvidencePosted Date: Jan 17 2024

　　GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. Our goal is to be one of the most innovative, best performing, and trusted healthcare companies.

　　The Senior Director Respiratory Regulatory Life Cycle Management is responsible to ensure the development and execution of appropriate regulatory life-cycle strategy(s) and their execution for assigned products to ensure meets the needs of the business.  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 life cycle management and expansion commensurate with the available data.  Position will have direct reports.

　　Key Responsibilities:

　　In performing the role, the job holder will be responsible for:

　　Proactively develop and implement a regulatory life-cycle management and expansion strategy focused on the key markets identified. In doing so, will promote innovative regulatory approaches when they benefit advancement of a given strategy.

　　Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective and the impact this will have on the regulatory strategy for product.

　　Lead regulatory interactions and the regulatory review processes ensuring effective engage with Health Authorities

　　Ensure effective partnerships with stakeholders and senior leaders across GRA, safety, global medical and commercial teams and local regulatory counterparts in key markets

　　Ensure compliance with regulatory requirements and delivery of unfulfilled regulatory commitments

　　If Global Regulatory Lead, act as single point of accountability for regulatory on the medicine development/commercial teams, lead the Regulatory Matrix Team, and deliver the required Regulatory Work Package(s).

　　Direct line management responsibility and member of the Established Products (EP) leadership team

　　Ability to attract talent, challenge, manage performance and develop direct reports

　　Assist as needed in managing the Workforce plan, resource demands (including above project work and staff recruitment) and in managing EP budgetJob related Experience:Leadership

　　Consistent ability to foster strong matrix working.  Proven track record of facilitating groups of individuals to work together on creating solutions and developing regulatory life-cycle strategies, proactively seeking information and insight from a broad range of sources and weight benefits and risks before making important decisions.

　　Supports team members to appreciate how their ideas can be combined in order to create value for the whole group. Ability to manage cultural diversity and be effective in leading global teams

　　Ability to lead change and communicate difficult messages.  Capable of seeing opportunities and revising process or approach to reduce barriers for others to be able to deliver more.  Ensures implementation of longer-term plans or delivery of large-scale projects

　　Proven ability to build strong personal networks, both within and outside GSK and use them to secure appropriate support and outcome for a project.

　　Shows a constant focus on improving performance and excellence in all tasks.  Challenges and questions ways of working to seek improved process.  Adds value through quantitative goal setting and provision of feedback to raise collective performanceBusiness Skills

　　Delivers all communication with clarity, impact, and passion, tailored to the audience.  Commands attention and interest through the use of a range of communication techniques and styles.  Makes complex ideas simple. Is able to effectively interact across all levels and areas within the company.

　　Good listening and comprehension skills; abil ty to adapt personal style to a given audience; takes ownership and is productive in addressing potential problems before they become an issue

　　Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulations.  Capable of synthesizing complex information globally to ensure appropriate assessment of the "big picture" for a project

　　Proven ability to make sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints.

　　Strong overall business acumen.  Understands the needs of other functions.  Understands the competitive landscape in the commercial space to support life-cycle management and expansion strategies.

　　Ability to influence and manage conflict in a consensus building manner showing sensitivity to building productive business relationships; demonstrates excellent ability to have conversations in which there may be varying and different opinions or approaches/options.Technical

　　Ability to interpret data and advice from regulatory authorities objectively, often in the face of strongly held competing views.

　　Strong overall clinical acumen to support life cycle management and expansion. Good understanding of the therapy area.Compliance

　　Clear understanding of the importance of following all applicable laws and regulations and role modeling GSK expectations and values

　　Basic Qualifications

　　Bachelor's degree in biological or healthcare science or a related field with applicable experience

　　Extensive years in industry with several years of demonstrated leadership and influence

　　Extensive knowledge of relevant therapeutic area.

　　Extensive experience of leading life cycle expansion strategies and delivering submission and approval activities including track record of organizing and executing successful milestone meetings and proven track record of successful relationship with one or more Health Authority

　　Extensive knowledge of life-cycle management requirements in priority markets and sound knowledge globally.  Ideally, proven experience of leading regulatory activities outside local region.Preferred Qualifications

　　Masters or PhD

　　Ideally, has established an external network into other pharmaceutical companies and recognized internally and externally as an expert broadly, or in specific areas, of regulatory affairs.

　　*LI-GSKWhy Us?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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

　　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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

　　As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. Th