Senior Director Respiratory Regulatory Life Cycle
il y a 1 semaine
Site Name:
UK - London - Brentford, Belgium-Wavre, Durham Blackwell Street, Upper Providence
Posted Date:
Jun
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 GRL, act as single point of accountability on the MDT/MCT, lead the Regulatory Matrix Team, and deliver the required Regulatory Work Package(s).
- Direct line management responsibility and member of the 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 budget
Job 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 lifecycle 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 longerterm plans or delivery of largescale 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 performance
Business 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; ability 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 lifecycle 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
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