Associate Director, Regulatory Affairs-CMC

Job Description

Role Overview:

The Associate Director of Regulatory Operations Content Management will serve as a strategic business partner and subject matter expert (SME) supporting the advancement of Regulatory Operations capabilities across submission planning, content management, and registration management within a dynamic digital and AI-enabled pharmaceutical environment.

This role will partner closely with Regulatory Affairs, CMC, Quality, IT, Supply Chain, and global business stakeholders to support operational strategy, digital transformation, process optimization, and scalable regulatory execution across multiple therapeutic modalities and organizational functions within Reg CMC.

The ideal candidate combines strong CMC operational expertise with sound business judgment, effective communication skills, and the ability to influence change. This individual will help support digital initiatives, contribute to modernization efforts, and enable future-state regulatory capabilities that improve scalability, efficiency, and readiness for evolving health authority expectations and AI-enabled ways of working.

Regulatory Operations Support:

• Support long-term Regulatory Operations strategy aligned with enterprise Regulatory Affairs and CMC objectives.
• Help define governance models, operating standards, and business processes that promote consistency, compliance, scalability, and operational excellence.
• Contribute to cross-functional initiatives that improve regulatory effectiveness, accelerate submission execution, and reduce operational complexity.
• Identify opportunities to leverage automation, AI, structured content, and digital technologies to enhance Regulatory Operations.
• Support strategic planning, business case development, and executive-level communication as needed.

Content Management:

Serve as the subject matter expert supporting enterprise regulatory content capabilities by:

• Supporting the enterprise content management strategy across Regulatory CMC.
• Contributing to governance for content lifecycle management, structured authoring, content reuse, metadata, taxonomy, and document standards.
• Supporting initiatives that improve document quality, consistency, reuse, and inspection readiness.
• Partnering with Regulatory authors and functional SMEs to optimize authoring processes and reduce redundant content creation.
• Championing structured content management and modular content strategies that enable AI, automation, and future regulatory submission models.
• Supporting implementation and optimization of Regulatory Information Management (RIM), Document Management Systems, and content management platforms.

CMC Regulatory Operations Expertise:

• Serve as a strategic partner supporting CMC regulatory activities and submissions.
• Collaborate with Regulatory Operations to support standards that align with global requirements for Health Authority submissions.
• Provide operational guidance for complex CMC submission requirements, lifecycle management, and global regulatory coordination.
• Partner with CMC Regulatory Affairs and technical teams to support product development, manufacturing changes, and post-approval activities.

Strategic and Operational Support:

• Support global regulatory operations strategies and modernization efforts aligned to business priorities.
• Contribute to roadmaps, governance, and cross-functional alignment across business functions.
• Help ensure operational processes support compliance, inspection readiness, and scalability.

Technical and Business Release Oversight:

• Support release activities by assessing technical changes, business impacts, and coordination needs.
• Help manage staggered release schedules, readiness activities, and continuity of execution.
• Identify risks, clarify gaps, and support communication, testing, and training.

Leadership and Stakeholder Engagement:

• Influence and collaborate effectively across senior leaders, global teams, and cross-functional organizations.
• Lead or support governance meetings, strategic discussions, operational reviews, and executive presentations.
• Mentor and coach Regulatory CMC staff as needed while fostering a culture of innovation, accountability, and continuous improvement.
• Build strong partnerships across Regulatory Affairs, Quality, IT, Regulatory Operations, RIM, Supply Chain, and external partners.

Digital Transformation and Innovation:

• Support implementation and adoption of digital regulatory platforms, AI-enabled tools, automation capabilities, and operational technologies.
• Serve as a business partner for future software releases, platform enhancements, and emerging digital capabilities.
• Evaluate emerging technologies and assess business applicability.
• Help establish digital governance, standards, and best practices.
• Collaborate with IT, business stakeholders, and vendors to define system requirements and future-state operating models.
• Support enterprise automation and process modernization initiatives.

KPI and Data Analytics:

• Support KPI strategy aligned with organizational objectives.

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