Assoc. Dir, Regulatory Affairs-CMC

MSD; Rahway, West Point (NJ, PA); Hybrid; GBP 108,000 - 169,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision

401(k)

Job summary

Merck & Co., Inc. in Rahway, NJ (Hybrid) seeks an Associate Principal Scientist for Regulatory CMC Digital Innovation. You will advance AI-enabled regulatory authoring and partner with Regulatory CMC, R&D, and Manufacturing to optimize digital workflows.

The role requires 5+ years in pharma/biotech with a strong Regulatory CMC background and experience implementing AI tools in regulated environments. A hybrid work model and bonus potential are offered.

Qualifications

• Minimum BS or equivalent in Science, Regulatory, or Computer Science preferred.
• Minimum of five years in pharma/biotech with Regulatory CMC/Regulatory Affairs focus.
• Hands-on experience delivering AI/digital tools in regulated settings.
• Experience mentoring on digital projects and technical workflows.

Responsibilities

• Drive AI-enabled regulatory authoring innovations and draft practical job aids.
• Stay updated on AI and digital tool advancements for Regulatory CMC processes.
• Lead cross-functional activities for AI authoring, automation, regulatory intelligence, and digital transformation.
• Help establish and embed the CMC digital/AI operating model across sites.
• Collaborate with Regulatory CMC Systems/Operations on digital solutions (e.g., Veeva).
• Serve as primary Regulatory CMC point of contact for digital tools and reporting.
• Partner across divisions to identify shared digital opportunities and ensure data handoffs between manufacturing, research, and regulatory.
• Champion enterprise-wide AI adoption through networks and training activities.
• Mentor digital project teams including GRACS interns to build AI-enabled authoring capabilities.

Skills

Change Management

Collaboration

eCTD

Emerging Technologies

Interpersonal Relationships

Liaison Work

Manufacturing Processes

Multitasking

Project Leadership

Regulatory Affairs Management

Regulatory Compliance

Regulatory Documents

Regulatory Experience

Regulatory Management

Regulatory Reporting

Regulatory Strategy Development

Regulatory Submissions

Stakeholder Partnerships

Education

BS or equivalent in Science/Regulatory/Computing

Tools

Veeva

Job description

Associate Principal Scientist, Regulatory CMC Digital Innovation

Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Rahway, NJ or West Point, PA

The Associate Director, Regulatory CMC Digital Innovation is a key execution and enablement-focused role reporting to the Executive Director of Regulatory CMC Digital Innovation. The role will focus on developing digital and AI (Artificial Intelligence) innovations and solutions across all aspects of Regulatory CMC workflows. This individual will serve as a subject matter expert (SME) to help Regulatory CMC teams develop, adopt, implement, and maximize digital and AI tools to drive productivity and operational excellence. Additionally, this role will link Regulatory CMC initiatives to GRACS-wide projects and broader Enterprise Digital Initiatives and partnering closely with counterparts (in our Research & Development Division and our Manufacturing Division) to develop and implement integrated solutions.

Responsibilities

• AI-Enabled Authoring & Innovation: Drive the advancement of AI-enabled regulatory authoring capabilities (including Module 2/3 authoring innovations), drafting practical job aids, and continuously identifying novel generative AI drafting opportunities.
• Emerging Tech Advocacy: Keep abreast of rapid technological advancements (the latest AI, machine learning, digital tools, etc.) and assessing their utility for Regulatory CMC processes.
• Cross-Functional Collaboration: Lead and coordinate cross-functional activities relating to development of AI authoring, process automation, regulatory intelligence, and digital transformation initiatives.
• Digital Operating Model Support: Partner in establishing, communicating, and embedding the CMC digital/AI operating model to connect, align, and scale localized AI efforts with broader enterprise digital strategies.
• Partner with the Regulatory CMC Systems/Operations group regarding the development of digital solutions impacting our regulatory platforms (e.g., Veeva) as needed.
• Application Ownership & Reporting: Serve as the primary Regulatory CMC point of contact for selected key digital tools and platforms (such as the ERA App), and support CMC digital priority tracking and progress reporting.
• Research & Development Division-Manufacturing Division Partnerships: Work collaboratively across our Divisions to identify shared digital opportunities, co-develop cross-functional solutions, and ensure smooth data and process handoffs between manufacturing, research, and regulatory.
• Advocacy & Change Management: Actively champion enterprise-wide AI adoption by participating in champion networks (e.g., AI Pioneers Champions Network), coordinating feedback loops, and driving change management and training activities.
• Mentorship & Community Building: Propose, lead, and mentor digital project teams—including guiding GRACS CMC summer intern projects focused on AI-enabled authoring and process improvement—while fostering collaboration across the broader AI/Digital Enablement community.

Education

• Minimum BS or equivalent Scientific, Technical, or Regulatory degree (focus on chemistry, biology, pharmacy, computer science, or data analytics preferred).

Required Experience

• Minimum of five (5) years of experience in the pharmaceutical or biotech industry, with a strong background in Regulatory CMC, Regulatory Affairs, or related pharmaceutical technical operations.
• Hands-on experience developing, implementing, or optimizing digital tools, automation, and modern AI/LLM solutions in a regulated business setting.
• Demonstrated experience delivering enterprise-wide solutions that improve business outcomes.
• Experience in technical change management, with a capability to design repeatability assessments, job aids, and training materials for end-users.
• Experience mentoring and coaching colleagues or interns on digital projects and technical workflows.
• Strong collaboration and communication skills, with a proven ability to work effectively in a matrix environment across various functional units (such as research, manufacturing, and IT).
• Strong organizational and project coordination skills, with the ability to manage multiple overlapping initiatives simultaneously.
• Up to 10% Travel.

Required Skills

• Change Management
• Collaboration
• Electronic Common Technical Document (eCTD)
• Emerging Technologies
• Interpersonal Relationships
• Liaison Work
• Manufacturing Processes
• Multitasking
• Project Leadership
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Documents
• Regulatory Experience
• Regulatory Management
• Regulatory Reporting
• Regulatory Strategy Development
• Regulatory Submissions
• Stakeholder Partnerships

The salary range for this role is $142,400.00 - $224,100.00

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.

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.

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 affirmative action requirements for protected veterans and individuals with disabilities.

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.

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.

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: 09/1/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.