Director, Regulatory Affairs-CMC
Merck · North Wales (upper Gwynedd), PA +1 more
RegulatoryFull-time$173k–$273kCompany career page
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Role summary
Director-level position overseeing CMC content management strategy, governance, and digital enablement across the regulatory lifecycle. The role partners with regulatory, quality, and IT stakeholders to modernize content processes, implement digital tools, and ensure compliance with global standards.
What they're looking for
- Bachelor's degree required; advanced degree preferred in Life Sciences, Regulatory Affairs, or related field
- Extensive experience in CMC content management, regulatory operations, or pharmaceutical operations
- Demonstrated leadership of content management strategy, governance, or process improvement initiatives
- Experience with digital transformation, system implementation, or content platform optimization
- Strong expertise in regulatory content management, structured authoring, metadata governance, or document lifecycle management
- Proven ability to influence across complex global and cross-functional environments
What you'll be doing
- Define and lead CMC content management strategy, governance standards, and operating procedures across the content lifecycle
- Establish and monitor performance metrics for content quality, compliance, cycle time, and operational effectiveness
- Lead digital tool implementation and adoption to support content management capabilities and future digital workflows
- Collaborate with regulatory, quality, IT, and business stakeholders to align content processes with compliance and business priorities
- Champion structured authoring and modular content approaches to improve efficiency and enable automation opportunities
Privacy & handoff
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