Global Regulatory Affairs - Manager, Specialty Therapeutic Group
Are you a Regulatory Affairs expert looking for an exciting opportunity to develop your career and advance your personal development journey within an innovative, collaborative, inclusive and diverse Research and Development organisation? Then this role could be for you!
We are looking for a talented Manager with strong global regulatory affairs knowledge/experience and interpersonal skills to join our GSK Specialty Therapeutic Group, Global Regulatory Affairs team in West London, UK. As a valued member of the Regulatory Matrix team(s) and the asset project team(s), you will be empowered to develop appropriate regional regulatory strategy(s) and ensure their execution for assigned asset(s), consistent with Medicines Development Strategy. With your strong regulatory expertise and excellent communication/negotiation skills, you will lead regulatory interaction activities and the review processes in regions outside US, with focus in EU, China, Japan and Emerging Markets.
About the role
Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process/policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.
Responsibilities and Accountabilities
Accountable to Global Regulatory Lead and Global Regulatory Therapeutic Area Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. In conducting this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with local regulatory agencies. Work closely with local/regional commercial team to secure best possible labeling commensurate with the available data. Lead interactions with local/regional regulatory authorities. In performing the role, the job holder will be responsible for:
- Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking into account the needs of other regions globally
- Implementation of the regional strategy(s) in support of the global project objectives
- 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 life from Commit to Medicine Development
Competencies and Capabilities
- Strong oral and written communication skills. Capable of delivering key communications with clarity, impact and passion, tailored to the audience
- Ability to foster strong matrix working. Involve people in issues that affect them. Facilitate dialogue between team and matrix members so they understand links between their different ideas and perspectives. Bring team members into the discussion so they can contribute their ideas. Capable of developing and recommending strategies for change. Developing personal networks within GSK and capable of using them to secure appropriate support and outcome for a project
- 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. Recognise potential long-term issues for projects
- Ability to make sound decisions. In doing so, the job holder will use a range of sources and weigh benefits and risks before making important decisions
- Show a constant focus on improving performance and excellence in all tasks. Challenge and question ways of working to seek improved process. Seek to raise levels of performance by establishing or improving process
Experience, Skills and Specialised Knowledge
In addition to your regulatory expertise, the successful candidate will demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative and leadership.
- Bachelor degree or preferably PhD in biological or healthcare science
- Experience in all phases of the drug development process in Regulatory Affairs
- Experience in clinical aspects of the drug development process in Regulatory Affairs
- Capable of leading regional development, submission and approval activities in local region(s), including regulatory interactions and negotiations
- Extensive knowledge of clinical trial and licensing requirements in all major countries in the region outside the US, with focus on EU, China, Japan and Emerging Markets, and ideally knowledge of other key Agency processes in these regions
- Knowledge of relevant area of medicine, and ability to further develop necessary specialist knowledge for the asset or area of medicine
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