Head of CMC Regulatory Affairs – Strategy and Operations

Remember to check your CV before applying Also, ensure you read through all the requirements related to this role. * Oversee digital modernization of core CMC RA platforms (e.g., RIM) and integration across systems. * Stand up for CMC RA (with enterprise thinking) and oversee a digital/AI fluency and enablement team aligned to strategic priorities. * Create guidelines, systems, and processes for CMC RA knowledge management, in alignment and partnership with any broader initiatives in this space across the enterprise. * Lead workforce capability design, training strategy, and upskilling initiatives. **Domain Knowledge & Experience *** Requires a PhD or MS with 14+ years of relevant professional experience, or BS with 16+ years of relevant professional experience – a degree in chemistry or a related scientific discipline is strongly preferred. * Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives. * Experience with CMC requirements for drug development of a range of product modalities. * Comprehensive understanding of the biopharmaceutical industry, R&D, and product commercialization, including the regulatory framework. * Experience designing, selecting, and implementing digital tools such as RIM, structured content authoring, LIMS, or GenAI applications with an enterprise mindset. * Understanding of structured content, automation, and enterprise knowledge systems. * Strategic thinking and ability to influence and constructively challenge the status quo. * Strong business acumen. * Ability to blend strategic acumen, regulatory fluency, and operational rigor with a strong background in change leadership, data governance, and digital transformation. * Experience in managing organizational cross-functional initiatives and/or business operations programs. * Ability to design and optimize organizations. * Excellent organizational and communication (both written and verbal) skills with all levels of an organization. * Ability to work and influence within a matrixed environment and regularly collaborate with cross-functional teams across Technical, Research, and Development. xsgimln * Ability to manage multiple priorities, to draw out diverse views, and to show tact and discretion in challenging situations.