Associate Director, Regulatory Affairs-CMC

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

#GRACS

#EligibleforERP

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

Preferred Skills

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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.  As a 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 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

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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

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.