Position Summary: Are you a dynamic Regulatory Affairs professional seeking to work for a global leader in the OTC industry. Do you have global expertise in Regulatory Intelligence and enjoy interaction with Health Authorities? If so, please read on.
GSK Consumer Healthcare R&D is looking to identify a Senior Manager on our Global Regulatory Intelligence and Policy team to support our global ambition, to provide consumer access to these leading self-care products.
The selected candidate will help support GSK CH markets’ engagement with government regulators and Ministries of Health at a policy and regulatory level; be responsible to track interpret and escalate discussions around new legislation with potential to impact GSK, and to help markets ensure that the voice of the GSK is heard with regulators.
The position is based in GSK‘s Warren, NJ (USA) site, and will report to the Head: Global Regulatory Affairs and Policy (Weybridge, UK).
Job Purpose: Support development of effective practices and processes, in partnership with subject matter experts in categories / markets / regions, to monitor and respond to regulatory change that impacts GSK CH’s innovation and growth objectives. To identify and communicate timely regulatory intelligence to a broad range of CH stakeholders; highlighting emerging opportunities / threats, and providing an assessment of business impact. Development and communication of cohesive and consistent GSK CH external regulatory positions globally, including alignment with GSK Pharma and Government Affairs Public Policy and Patient Advocacy (GAPPPA) Proactively support categories / markets develop external engagement strategies to respond to evolving OTC regulation, to enable a positive self-care environment and minimize regulatory burden. Develop and share best practice for specific regulatory subject areas / projects. Develop relationships with forward looking / thinking trade associations, advocacy organizations, consultants, and with limited key Health Authorities as required.
Key Position Responsibilities: Develop and share toolkits / best practice process incl. KPIs, tracking effective execution of key priorities and report on the GSK Cx impact of evolving government regulations. Provides effective summaries and status updates on product / project and other regulatory activities to Senior Management and key internal /external stakeholders. Develop relationships with selected external (regulators, trade associations) and internal (GAPPPA, GSK Rx and Vx) stakeholders to advocate GSK Cx intel and policy agenda. Ensure oversight of GSK Cx GRA MoH policy engagement: assures no misalignment of company positions across functions and the enterprise. Responses to issues and crises, either independently or in partnership with other critical functions. Ensures GSK values and expectations are adhered to in all activities. Supports training and development for central and local staff in effective external engagement.
Bachelor's Degree in Life Sciences or Related Significant understanding and experience (5-10 years) working in the consumer health OTC industry or government. Significant knowledge of international regulations governing classification, composition, labelling and claims of non-prescription drugs, cosmetics, specialist nutrition / herbals, medical device and digital technologies, with an understanding and appreciation of the borderlines between various classifications. Possess an understanding of key Health Authority practices / trends. Experience working with regulatory KOLs, and experience in trade association working groups. Knowledge of R&D processes and the associated commercial environment with a demonstrated grasp of business and brand strategic thinking.
Advanced Degree in Life Sciences or Related 10+ years of OTC Regulatory Experience Effective at developing, documenting positions, status and processes. Demonstrated ability to apply sound problem solving principles, techniques and judgement in making decisions to drive assigned programme. Demonstrated ability to support / lead team and project activities. Proficient in use of IT and key software/systems.
Internal Number: WD167908
GSK Consumer Healthcare is one of the world's largest consumer healthcare companies. Our purpose is to help more people around the world to do more, feel better and live longer with everyday healthcare products. We have a heritage that goes back over 160 years. We own some of the world's best loved healthcare brands, including Sensodyne®, Theraflu®, Excedrin®, Nicorette® and NicoDerm®CQ®, Flonase® and TUMS®.
Our goal is to build a global, growing business we call a Fast Moving Consumer Healthcare company, dedicated to everyday healthcare with all of the scientific expertise and quality guarantees that demands, working at the speed and with the genuine consumer understanding the modern world expects.