Associate Director, Regulatory Affairs-CMC

MSD•North Wales, PA

1d•$142,400 - $224,100•Hybrid

About The Position

The Associate Director of Regulatory Operations Content Management serves as a strategic business partner and subject matter expert supporting Regulatory Operations capabilities across submission planning, content management, and registration management in a digital and AI-enabled pharmaceutical environment. The role partners with Regulatory Affairs, CMC, Quality, IT, Supply Chain, and global stakeholders to support operational strategy, digital transformation, process optimization, and scalable regulatory execution across therapeutic modalities and organizational functions within Regulatory CMC. The position supports enterprise regulatory content capabilities, including content lifecycle governance, structured authoring, content reuse, metadata, taxonomy, and document standards. It also supports CMC regulatory activities and submissions, global regulatory operations modernization, digital platform adoption, system release readiness, KPI strategy, and data-informed decision-making. The role collaborates with senior leaders and cross-functional teams, contributes to governance and executive communications, and may mentor and coach Regulatory CMC staff. The position is based primarily in North Wales (Upper Gwynedd), Pennsylvania, with hybrid work arrangements and 10% travel. Relocation is not offered. The role is a regular employee position, and visa sponsorship is not available.

Requirements

Bachelor’s degree required in Life Sciences, Regulatory Affairs, Information Systems, or a related field; an advanced degree is preferred.
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.
Strategic thinking and business acumen, with ability to connect functional priorities to broader organizational objectives.
Executive presence and influence, with ability to communicate clearly, build credibility, and drive alignment.
Cross-functional collaboration 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.
Strong analytical and problem-solving capability, including assessing complex issues, synthesizing information, and making sound, action-oriented decisions.
Required skills listed in the posting include 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 Development, Regulatory Submissions, and Stakeholder Partnerships.

Nice To Haves

System release management and impact assessment.
Understanding end-to-end business processes and evaluating upstream and downstream impacts of system changes.
Experience 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.
Experience with regulatory, content management, and structured data platforms.
Hands-on experience with Veeva Vault (RIM and QMS), Lorenz docuBridge, Appian, and Microsoft Power BI.

Responsibilities

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 to improve regulatory effectiveness, accelerate submission execution, and reduce operational complexity.
Identify opportunities to use automation, AI, structured content, and digital technologies to enhance Regulatory Operations.
Support strategic planning, business case development, and executive-level communication.
Support enterprise regulatory content strategy and governance for content lifecycle management, structured authoring, content reuse, metadata, taxonomy, and document standards.
Support initiatives that improve document quality, consistency, reuse, and inspection readiness.
Partner with Regulatory authors and functional subject matter experts to optimize authoring processes and reduce redundant content creation.
Champion structured content management and modular content strategies that enable AI, automation, and future regulatory submission models.
Support implementation and optimization of Regulatory Information Management, Document Management Systems, and content management platforms.
Serve as a strategic partner supporting CMC regulatory activities and submissions.
Collaborate with Regulatory Operations to support standards aligned with global Health Authority submission requirements.
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.
Support global regulatory operations strategies and modernization efforts aligned with business priorities.
Contribute to roadmaps, governance, and cross-functional alignment across business functions.
Help ensure operational processes support compliance, inspection readiness, and scalability.
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.
Influence and collaborate 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 innovation, accountability, and continuous improvement.
Build partnerships across Regulatory Affairs, Quality, IT, Regulatory Operations, RIM, Supply Chain, and external partners.
Support implementation and adoption of digital regulatory platforms, AI-enabled tools, automation capabilities, and operational technologies.
Serve as a business partner for software releases, platform enhancements, and emerging digital capabilities.
Evaluate emerging technologies and assess their 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.
Support KPI strategy aligned with organizational objectives and 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.