The Director, Global Regulatory Affairs
ensures the development of appropriate regional and global regulatory strategies and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal is achieved both as a component of an overall regional or global regulatory approach and ensures compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.
This role will provide YOU
the opportunity to lead key activities to progress YOUR
career, these responsibilities include some of the following:
- Ensuring the regulatory strategy will deliver the needs of the local region(s), taking in to account the needs of other regions globally
- Implementation of the regional strategy(ies) in support of the project globally
- Lead regulatory interactions and the review processes in local region
- Ensuring appropriate interaction with regional commercial teams in local region
- Ensuring compliance with regional requirements at all stages of product lifecycle
We are looking for professionals with these required skills to achieve our goals (must-have):
- Bachelor Degree
- Experience in all phases of the drug development process in regulatory affairs
- Experience in leading regional development, submission and approval activities in local region(s)
- Experience in organizing and executing successful milestone meetings with one or more Health Authority
- Knowledge of clinical trial and licensing requirements in the US & Globally
- Knowledge of Drug Development or Product Development
- External network experience
If you have the following characteristics, it would be a plus:
Why GSK? Our values and expectations
- Advanced Degree in Biological OR Health Science
- Excellent communication skills, ideally in writing and verbally.
- Proven ability to deliver key communication with clarity, impact and passion.
- Commands attention and interest through use of appropriate communication techniques.
- Proven ability to foster strong matrix working.
- Capable of facilitating groups of individuals to work together on creating solutions.
- Ability to lead change and communicate difficult messages.
- Able to implement plans and hold self and teamaccountable for delivery of short and medium term goals.
- Proven ability to build strong personal networks and use them to secure appropriate support and outcome for a project.
- Developing an external network.
- Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome.
- Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Health Authorities and ensuring compliance with regulations in all regions. Will seek information from a broad range of sources, within and outside the normal range of enquiry to understand wider context.
- 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. In doing so, the job holder will use all available sources of information and weight benefits and risks before making important decisions.
- Shows a constant focus on improving performance and excellence in all tasks.
- Challenges and questions ways of working to seek improved process. Establishes team goals and uses to seek to improve performance, with ability to set challenging but realistic targets.
- Ability to provide coaching, mentoring and performance feedback to regulatory colleagues.
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.
*LI-GSK *This is a job description to aide in the job posting, but does not include all job evaluation details.
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