Assoc. Dir, Regulatory Affairs-CMC

Job description

Job Description Associate Principal Scientist, Regulatory CMC Digital Innovation Rahway, NJ or West Point, PA 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. 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 CMC, Regulatory Compliance, Regulatory Documents, Regulatory Experience, Regulatory Management, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Stakeholder Partnerships Preferred Skills: 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. 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: 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 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. 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 appli