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MSD
MSD
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MSD is a global biopharmaceutical company advancing medicines and vaccines for major health challenges, including cancer, infectious diseases, cardiovascular and metabolic conditions, and prevention-focused care. Known as Merck & Co., Inc. in the United States, Canada, and Puerto Rico, MSD combines scientific research with development and commercial expertise to bring healthcare solutions to people and animals.

Its work spans Human Health, Animal Health, and Research & Development, creating opportunities for professionals across scientific, clinical, commercial, operational, and corporate teams. With activities in regions around the world, MSD’s careers reflect its focus on research, collaboration, inclusion, and responsible progress in global health.

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Associate Director, Regulatory Affairs CMC Digital Innovation – MSD Hybrid

Lead digital and AI innovation across Regulatory CMC for MSD medicines, vaccines, and animal health products. Connect research, manufacturing, and regulatory operations through automation, modern authoring, and integrated technology solutions.

USUnited StatesNJNew JerseyPAPennsylvania
$142,400 – $224,100 / year
HybridFull-timeMiddleSeniorEnglish RequiredCompliance

Description

  • Create digital and AI solutions that improve Regulatory CMC workflows
  • Act as the subject matter expert for Regulatory CMC digital innovation and AI
  • Advance AI-enabled regulatory authoring, including innovations for Module 2 and Module 3
  • Develop practical job aids and identify opportunities for generative AI-assisted drafting
  • Evaluate emerging AI, machine learning, and digital technologies for Regulatory CMC use
  • Lead cross-functional work spanning AI authoring, process automation, regulatory intelligence, and digital transformation
  • Support the CMC digital and AI operating model while aligning local initiatives with enterprise strategy
  • Collaborate with Regulatory CMC Systems and Operations on digital solutions for platforms such as Veeva
  • Own designated digital tools and platforms, including the ERA App
  • Monitor CMC digital priorities and communicate progress
  • Work across research, manufacturing, and regulatory divisions to identify opportunities and build integrated solutions
  • Promote enterprise AI adoption through champion networks, feedback channels, change management, and training
  • Lead and mentor digital project teams, including GRACS CMC summer intern initiatives
  • Report to the Executive Director of Regulatory CMC Digital Innovation
  • Travel up to 10%

Requirements

  • Bachelor’s degree or equivalent in a scientific, technical, or regulatory discipline; chemistry, biology, pharmacy, computer science, or data analytics preferred
  • At least five years of experience in the pharmaceutical or biotechnology industry
  • Strong experience in Regulatory CMC, Regulatory Affairs, or related pharmaceutical technical operations
  • Hands-on experience developing, implementing, or optimizing digital tools, automation, and modern AI or LLM solutions in a regulated business environment
  • Track record of delivering enterprise solutions that improve business outcomes
  • Experience with technical change management, including repeatability assessments, job aids, and training materials
  • Experience mentoring and coaching colleagues or interns on digital projects and technical workflows
  • Ability to collaborate effectively in a matrix organization spanning research, manufacturing, and IT
  • Strong organizational and project coordination skills, with the ability to manage multiple concurrent initiatives
  • Knowledge of change management, eCTD, emerging technologies, manufacturing processes, project leadership, Regulatory Affairs management, Regulatory CMC, regulatory compliance, regulatory documents, regulatory operations, regulatory reporting, regulatory strategy development, regulatory submissions, and stakeholder partnerships
  • Willingness to travel up to 10%
  • Must reside in the United States or Puerto Rico
  • Visa sponsorship is not available

Benefits

  • Annual bonus and long-term incentive, where applicable
  • Medical, dental, and vision coverage
  • Additional insurance benefits for employees and their families
  • Retirement benefits, including a 401(k) plan
  • Paid holidays
  • Vacation time
  • Compassionate and sick leave
  • Hybrid work arrangement
  • Mentorship and career development opportunities
  • Relocation assistance is not provided

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