Within Global Regulatory Affairs (GRA) at GSK, our Regulatory Professionals work within one of six Therapeutic Groups (Respiratory, Immuno-Inflammation, Oncology, Cardiovascular/Metabolic, Neuroscience/ Infectious Diseases, and Dermatology). Regulatory Professionals comprising each Therapeutic group are led by a Global Head and support R&D projects as Global Regulatory Leads and Regional Regulatory Leads.
At GSK, we have a commitment to deliver products to treat a wide range of autoimmune diseases, as well as antibacterials to help address the growing threat of antibacterial resistance. To support this commitment, we currently have opportunities in Immuno-Inflammation and Infectious Diseases Global Regulatory Affairs.
As a manager in Global Regulatory Affairs, the incumbent will act as a Regional Regulatory Leader for a given asset(s). Regional Regulatory Leaders are accountable for regulatory interactions in their region, being a core part of a Regulatory Matrix Team and a member of the extended Project Team. Hence, they will coordinate regulatory interactions with Health Authorities and activities associated with application review processes in their region, as well as ensure appropriate interaction with regional commercial teams. Regional Regulatory Leaders may also, at different times, act incrementally as a GRL for assigned assets in development, depending on experience.
Responsibilities and Accountabilities:
Accountable to the GRL and/or Global Regulatory Therapeutic Group Head for development of appropriate global and/or regional regulatory strategy(s) for assigned asset(s) and for delivery consistent with plans in the Medicines Development Strategy. This goal has to be achieved both as a component of an overall global development and commercialization strategy and while ensuring compliance with both internal GSK processes / policies and with regulatory requirements.
In performing the role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK and may involve representing GSK directly with the local regulatory authority.
Accountable for providing regional advice and decisions on regulatory strategy and action.
The job holder will be responsible for:
• Working collaboratively with the GLR, developing regulatory strategy(s) that will deliver the needs of the regions targeted in the development strategy(s), with an optimal reimbursable file
• Developing and maintaining a deep knowledge of relevant regulations, guidelines and regulatory precedent and leveraging such knowledge in formulating regulatory strategies
• Implementing the regional strategy(s) in support of the project globally
• Leading regulatory interactions with appropriate regulatory authorities, as appropriate based on experience
• Working closely with the GRL and/or Head of the Therapeutic Group in Global Regulatory Affairs and the clinical and medical teams to secure the best possible labelling commensurate with the available data.
• Ensuring compliance with GSK policies/procedures and regulatory requirements at all stages of the product life cycle from First Time in Human to Life Cycle Management
In addition, role holder will:
• Contribute to the evolution of the Global Regulatory Affairs efforts to embed quality and compliance aspects into regulatory processes
• Help educate the Regulatory Affairs Therapeutic Group and/or Global Regulatory Affairs or R&D more broadly regarding regulations, guidelines, and/or precedent that impact the development of assets in the assigned therapeutic area
• Interface with external vendors, e.g., CROs contracted by GSK clinical groups to conduct GSK studies, as GSK continues to explore out-sourcing activities as appropriate for the business
Competencies and Capabilities:
• Excellent written and verbal communication skills to deliver key communications with credibility, clarity, and impact within GSK matrix environment.
• Experience working with cross-functional teams in implementing sound development and registration strategies.
• Ability to proactively identify possible regulatory challenges and issues and to develop creative approaches to address, while balancing the expectations of Agencies 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 take sound decisions. In doing so, the job holder will use all available sources of information and weigh 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 processes. Establishes team goals and seeks to improve performance, with the ability to set challenging but realistic targets
PhD in biological or healthcare science
• Experienced in drug development and/or regulatory affairs in the biotechnology or pharmaceutical industry
• Experience of leading development, submission and/or approval activities
• Capable of organising and executing successful milestone meetings with one or more Health Authorities
• Broad knowledge of clinical trial and licensing requirements in all major countries in the assigned region; ideally knowledge of global requirements
• Experience in the Immuno-Inflammation/Autoimmunity or Infectious Diseases therapeutic areas, and ability to further develop necessary specialist knowledge relevant to the assigned product or area of medicine.