Job Description:
Accountable to the Global Regulatory Leader/Global Regulatory Therapeutic Group Head for development of appropriate regulatory strategy(s) for assigned asset(s) and for delivery consistent with plans in 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 regional regulatory requirements.
Responsibilities and Accountabilities ...
• Act as a point of Regulatory contact for the asset/group of assets for the TA team and management of GSK.
• Integrate all aspects of strategic & operational regulatory input to asset development; including: clinical, technical, non-clinical, regulatory liaison to ensure an aligned global RA strategy
• Input to the asset specific regulatory strategy, including Global Regulatory Plan (GRP) including ownership and accountability as needed;
• Provision of input to Asset Development Plans in order to optimise the label and ensure alignment with business objectives;
• Communication of relevant asset specific information to enable colleagues to prepare the external environment in a timely fashion;
• Driver for the lifecycle of the asset;
• Point of contact for Regulatory Agencies for asset (or oversight/support to regional points of contact to authorities)
• Contributions to tracking and impacting the evolving regulatory environment and policy/regulation development
• The role is critical for ensuring that the asset or assets for the assigned TA is/are registered and commercialized globally with high quality, optimal profile in most expedited fashion. It is essential to align regulatory, development and commercialization strategy globally to optimize the product offering, including product label to ensure best product available to patients.
• Owning and/or contributing to the regulatory strategy and its implementation for products within assigned area
• By securing acceptable yet innovative strategy, growing the GSK portfolio with a potentially revolutionary set of assets
Basic qualifications: • Scientific Degree such as Ph.D. or M.D or commensurate combination of scientific degree & experience
• Regulatory experience in development and life-cycle management; including supervisory/management experience in a business-driven environment – of projects and/or people
• Experience applying scientific knowledge including medicine, biology, infectious diseases, immunology, oncology, other therapeutic disease area, clinical trials management, statistics & epidemiology
• Experience applying Regulatory knowledge in situations requiring global expertise, exposure to guidelines, legislation, registration procedures including labeling, technical & non-clinical, regulatory authorities liaison
• Direct experience in the development of medicinal products, authority interactions and obtaining licenses
in different geographical areas
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