Senior Manager/Associate Director Global Regulatory Intelligence
Consumer Healthcare R&D is looking to identify a qualified candidate for a Senior Manager role in the 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).
• 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 minimise regulatory burden.
• Support markets' Ministry of Health / regulator engagement activities, providing assets (position papers, analysis), tools and tracking / KPI support.
• 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.
GlaxoSmithKline (GSK) is dedicated to improving the quality of human life by enabling people to do more, feel better, live longer. GSK is one of the world's leading research based healthcare companies, with over 100,000 employees in 150 countries across our Pharmaceuticals, Vaccines and Consumer Healthcare business. GSK Consumer Healthcare has a bold ambition to be the world's best Fast-Moving Consumer Healthcare (FMCH) company. Inspired by a winning culture and a science-led innovation approach, we have developed brands that are built around the needs of the millions of people who go online or walk into pharmacies, supermarkets and market stalls all over the world and choose our products first. We have a heritage that goes back more than 160 years, producing some of the world's best-loved healthcare brands including: Sensodyne, Panadol, Voltaren, Theraflu, Parodontax, Otrivin, Physiogel, Horlicks and Eno.
You may apply for this position online by selecting the Apply now button.
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