Associate Director, Regulatory Affairs-CMC
Merck · United States, Pennsylvania, North Wales Upper Gwynedd
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.
- Help establish performance measurement frameworks across functions.
- Drive data-informed decision-making through dashboards and insights.
- Contribute to governance for KPI development, reporting standards, and data quality.
Required Qualifications:
- Bachelor’s degree required; advanced degree preferred in Life Sciences, Regulatory Affairs, Information Systems, or related field.
- Experience in Regulatory Operations, Regulatory Affairs, or pharmaceutical operations.
- Deep expertise in regulatory content management.
- Experience supporting digital transformation initiatives and regulatory system implementations.
- Demonstrated ability to work across complex cross-functional organizations and multiple modalities.
- Strong communication, presentation, and stakeholder management skills.
Preferred Skills:
- System release management and impact assessment
- Understanding end-to-end business processes and evaluating upstream/downstream impacts of system changes
- Supporting multiple release cycles simultaneously and managing competing priorities across differing timelines
- Global submission lifecycle management, including coordination of submission content, workflows, and supporting systems
- CMC Regulatory Operations, including support for submission planning, execution, and operational oversight
- Metadata management and data governance principles
- Operational process design and workflow improvement
- AI and digital enablement strategies
- Regulatory, content management, and structured data platforms
- Hands-on experience with Veeva Vault (RIM and QMS), Lorenz docuBridge, Appian, and Microsoft Power BI
Leadership Competencies:
- Strategic thinking and business acumen, with the ability to connect functional priorities to broader organizational objectives
- Strong executive presence and influence, with the ability to communicate clearly, build credibility, and drive alignment
- Cross-functional collaboration skills, with the ability to partner effectively across technical, operational, regulatory, and business functions
- Change management capability, including leading through ambiguity, building buy-in, and supporting evolving priorities
- Innovation and continuous improvement mindset, with the ability to identify opportunities and drive practical enhancements
- Strong analytical and problem-solving capability, with the ability to assess complex issues, synthesize information, and make sound, action-oriented decisions
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Required Skills:
Content Management, Continuous Improvement Techniques, Data-Driven Decision Making, Digital Governance, Digital Transformation Initiatives, Document Control Systems, Electronic Common Technical Document (eCTD), Regulatory CMC, Regulatory Compliance, Regulatory Experience, Regulatory Information Management, Regulatory Operations, Regulatory Strategy Develo