Head of CMC Regulatory Affairs – Strategy and Operations

* 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.
* Ability to manage multiple priorities, to draw out diverse views, and to show tact and discretion in challenging situations.
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