Global Head of Regulatory Strategy

--- base: meta-keywords: meta-viewport: width=device-width, initial-scale=1.0 title: Global Head of Regulatory Strategy --- Global Head of Regulatory Strategy ================================== **The Opportunity** NonStop Consulting is partnering with an established international pharmaceutical organisation to appoint a Global Head of Regulatory Strategy. This is a high\-impact senior leadership opportunity for an accomplished Regulatory Affairs executive to shape and drive global regulatory strategy across an international pharmaceutical portfolio. The successful candidate will play a pivotal role in defining regulatory direction, influencing critical development and commercial decisions, and ensuring the successful execution of regulatory strategies across key international markets. In this senior leadership position, you will combine strategic oversight with hands\-on leadership, guiding an experienced international team and collaborating closely with key cross\-functional stakeholders. Key Responsibilities -------------------- * Global Regulatory Strategy: Define, lead and execute comprehensive regulatory strategies across multiple assets, from clinical development through registration, commercialisation and lifecycle management. * Strategic Leadership: Provide senior\-level regulatory guidance to global development teams, ensuring regulatory considerations are embedded in key portfolio and business decisions. * Regulatory Authority Engagement: Oversee high\-level interactions and negotiations with major international health authorities, including the FDA, EMA, PMDA and other relevant regulatory bodies. * Global Team Leadership: Lead, develop and mentor an international team of senior regulatory professionals, fostering accountability, collaboration and high performance. * Portfolio Oversight: Direct regulatory strategy and execution across key markets, including the US, Europe and selected international territories. * Executive Collaboration: Contribute to global regulatory leadership decisions, resource allocation, risk management and long\-term functional strategy. * Business Development Support: Provide strategic regulatory input into due diligence activities, potential licensing opportunities and portfolio assessments. * Operational Excellence: continuous improvement, innovation and the responsible adoption of new technologies to enhance regulatory effectiveness. * Cross\-Functional Partnership: Collaborate closely with Clinical Development, Medical Affairs, Quality, Commercial and other global functions to support business objectives. **Your Profile** ---------------- We are seeking an experienced, commercially aware and strategically minded Regulatory Affairs leader with the credibility to operate at the highest levels of an international pharmaceutical organisation. **Essential experience and qualification**s: * Extensive experience in Regulatory Affairs within the pharmaceutical industry. * Significant leadership and organisational management experience, ideally within an international regulatory function. * Proven experience defining and delivering global regulatory strategies across complex pharmaceutical portfolios. * Extensive experience engaging with major regulatory authorities, particularly the FDA and EMA, with broader international regulatory exposure. * Strong understanding of global drug development, registration, commercialisation and product lifecycle management. * Demonstrated ability to build, lead and develop international teams, including senior regulatory leaders. * Excellent stakeholder management, influencing and negotiation skills, with experience contributing to executive\-level decision\-making. * Strong strategic judgement, regulatory risk management capabilities and the ability to