Director, Regulatory Affairs-CMC

Job Description

Position Summary

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.

Key Responsibilities:

Content Management Leadership

· 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.

Operational Excellence and Governance

· 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.

Digital Enablement

· 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.

CMC Regulatory Operations Partnership

· 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.

Leadership and Stakeholder Engagement

· 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.

KPI and Data Analytics

· 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.

Required Qualifications

· 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.

Required Technical & Functional Expertise

Strong expertise in several of the following:

· 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

Experience with platforms such as:

· Veeva Vault

· Lorenz docuBridge

· Microsoft Power BI

Leadership Competencies

· 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

Required Skills:

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}

Preferred Skills:

Independent Judgment

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. Asa federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: 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

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

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.