Director, Regulatory Affairs-CMC
Merck
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Benefits offered by this job
Job summary
Merck is seeking a Director of CMC Operations Content Management and Digital Enablement to lead global content management across the lifecycle. You will partner with Regulatory Affairs, CMC, Quality, IT, and stakeholders to define the strategy, operating model, and governance for compliant, scalable, inspection-ready regulatory content processes.
The role combines deep regulatory content management expertise with leadership, process design, and change management to modernize the CMC content
Qualifications
- Bachelor’s degree required; advanced degree preferred in Life Sciences, Regulatory Affairs, Information Systems, or related field.
- Extensive experience in content management and regulatory operations with focus on CMC content processes.
- Experience leading content strategy, governance, and process improvement initiatives.
Responsibilities
- Define and lead the CMC content management strategy across the lifecycle.
- Establish governance, standards, and SOPs for content creation, review, and reuse.
- Drive global regulatory content processes to ensure inspection readiness and compliance.
- Lead digital enablement initiatives and mentor cross-functional teams.
Skills
Education
Tools
Job description
The Director, CMC Operations Content Management and Digital Enablement will serve as a leader and subject matter expert responsible for advancing global CMC content management capabilities across the content lifecycle, including authoring, review, reuse, governance, metadata, taxonomy, and document standards.
This role will partner closely with Regulatory Affairs, CMC, Quality, IT, and global business stakeholders to define and drive the content management strategy, operating model, and governance framework that support compliant, scalable, inspection-ready, and digitally enabled regulatory content processes.
The ideal candidate combines deep regulatory content management expertise with strong leadership, process design, and change management capabilities. This individual will play a critical role in modernizing the CMC content environment, enabling structured and modular content approaches, and supporting digital tools and AI-enabled ways of working that improve efficiency, consistency, and business value.
- Define and lead the CMC content management strategy across the content lifecycle.
- Establish governance, standards, and operating procedures for content creation, review, approval, reuse, maintenance, archiving, and retrieval.
- Serve as the enterprise SME for content management processes supporting CMC regulatory activities.
- Drive consistent application of document standards, metadata, taxonomy, and version control practices.
- Ensure content management processes support compliance, inspection readiness, and global regulatory requirements.
- Identify and implement opportunities to improve content quality, consistency, and reuse across the organization.
- Champion structured authoring and modular content approaches to enable more efficient content operations and future digital capabilities.
- Develop and maintain a scalable content management operating model aligned with business needs and regulatory expectations.
- Partner with cross-functional stakeholders to define roles, responsibilities, workflows, and governance forums.
- Lead process improvement initiatives that reduce duplication, improve efficiency, and strengthen control.
- Establish and monitor performance metrics related to content quality, cycle time, reuse, compliance, and operational effectiveness.
- Support audit and inspection readiness through strong content governance and data integrity practices.
- Lead the implementation, optimization, and adoption of digital tools that support content management capabilities.
- Partner with IT and business stakeholders to define business requirements, future-state workflows, and system enhancements.
- Evaluate and advance opportunities to leverage automation, AI, structured content, and digital technologies to improve content operations.
- Serve as a strategic business partner for content-related platform enhancements and digital capability roadmaps.
- Support adoption of content management systems, document management tools, and related regulatory platforms.
- Collaborate with CMC Regulatory Affairs and other stakeholders to ensure content management processes effectively support submission development and lifecycle activities.
- Align content management practices with global regulatory requirements and CMC business priorities.
- Provide operational guidance for content-related challenges, escalations, and continuous improvement opportunities.
- Contribute to the modernization of CMC regulatory operations through improved content processes and digital readiness.
- Influence and collaborate effectively across global teams, senior stakeholders, and cross-functional partners.
- Lead governance discussions, working sessions, and executive-level presentations related to content management strategy and performance.
- Build strong partnerships across Regulatory Affairs, Quality, IT, Supply Chain, and external vendors.
- Mentor and develop team members and foster a culture of accountability, innovation, and continuous improvement.
- Define KPI frameworks for content management performance and maturity.
- Develop reporting standards and dashboards to support data-driven decision making.
- Monitor key measures such as content quality, reuse, compliance, cycle time, and digital adoption.
- Present insights, trends, and recommendations to senior leadership to inform prioritization and improvement efforts.
- Bachelor’s degree required; advanced degree preferred in Life Sciences, Regulatory Affairs, Information Systems, or related field.
- Extensive experience in content management, regulatory operations, or pharmaceutical operations, with strong emphasis on CMC content processes.
- Demonstrated experience leading content management strategy, governance, or process improvement initiatives.
- Experience with digital transformation, system implementation, or content platform optimization.
- Strong communication, influence, and stakeholder management skills.
- Demonstrated ability to work effectively across complex global and cross-functional environments.
- Regulatory content management
- Structured content and modular authoring
- Metadata and taxonomy governance
- Document lifecycle management
- Global submission support processes
- Operational process design and continuous improvement
- Digital enablement strategies
- Veeva Vault
- Lorenz docuBridge
- Microsoft Power BI
- Strategic thinking and business acumen
- Executive presence and influence
- Content management and operational leadership
- Change management and organizational leadership
- Cross-functional collaboration
- Innovation and continuous improvement mindset
- Operational excellence
- Talent development and mentorship
- Strong analytical and problem solving capability
Business Process Improvements, Business Process Improvements, Change Management, Compliance Remediation, Cross-Functional Project Management, Data Reporting, Document Control Systems, Employee Training Programs, Executive Leadership, Executive Presence, High Performance Team Building, Influencing Skills, Innovation, Negotiation, Organizational Capability, Organizational Leadership, People Leadership, Policy Implementation, Prioritization, Process Improvements, Regulatory Affairs Management, Regulatory Submissions, Stakeholder Management, Strategic Leadership, Strategic Thinking {+ 2 more}
- Independent Judgment
The salary range for this role is
$173,200.00 - $272,600.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Regular
No relocation
No
No Travel Required
Hybrid
1st - Day
No
N/A
09/26/2026
* A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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