Associate Director, Regulatory Affairs-CMC

Merck; North Wales (Montgomery County); Hybride; USD 142 000 - 224 000; Plein temps

Résumé du poste

Merck in North Wales, PA seeks an Associate Director of Regulatory Operations Content Management to partner with senior leaders and SMEs, advancing regulatory content strategy across submissions and registration management in a digital/AI-enabled setting.

The role focuses on governance, standards, and scalable processes, driving modernization with AI, structured content, and RIM implementations. Collaboration across Regulatory CMC, IT, and external partners is essential.

Qualifications

• Bachelor's degree required; advanced degree preferred in Life Sciences, Regulatory Affairs, Information Systems, or related field.
• Deep expertise in regulatory content management and supporting digital transformation initiatives.
• Experience working across complex cross-functional organizations with strong communication skills.

Responsabilités

• Support long-term Regulatory Operations strategy aligned with enterprise objectives.
• Define governance models, operating standards, and scalable processes.
• Lead initiatives to improve regulatory effectiveness, automate content and AI-enabled capabilities.
• Partner with Regulatory authors and SMEs to optimize authoring and content reuse.
• Champion structured content management for AI, automation, and future submissions.
• Support implementation of Regulatory Information Management (RIM) and content platforms.

Connaissances

Content Management

Continuous Improvement

Data-Driven Decisions

Digital Governance

Digital Transformation

Document Control

eCTD

Regulatory CMC

Regulatory Compliance

Regulatory Operations

Regulatory Information Management

Regulatory Submissions

Regulatory Strategy

Stakeholder Management

Formation

Bachelor's degree

Advanced degree preferred

Outils

Veeva Vault

Lorenz docuBridge

Appian

Power BI

Description du poste

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.

Job Description

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.

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

• 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

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 Development,
• Regulatory Submissions,
• Stakeholder Partnerships

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.

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. As a Federal Contractor, We Comply With All Aspirants For Protected Veterans And Individuals With Disabilities. For More Information About Personal Rights Under The U.S. Equal Opportunity Employment Laws, Visit: EEOC Know Your Rights EEOC GINA Supplement 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.

Learn more about your rights, including under California, Colorado and other US State Acts.

The primary location for this posting is:

USA - Pennsylvania - North Wales (Upper Gwynedd)

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

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

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 11/10/2026

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.

Requisition ID: R423814