MSD
MSD

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.

Associate Specialist, Regulatory Affairs – Philadelphia Hybrid

Support FDA cover letters, submission planning, document tracking, and regulatory publishing for Merck. This full-time hybrid position is based in Philadelphia.

Description

  • Coordinate with stakeholders on regulatory and safety submissions
  • Help plan, execute, and manage accurate, timely regulatory submissions
  • Maintain established submission planning, tracking practices, and supporting systems
  • Contribute to pilots involving new tools and processes
  • Work collaboratively with colleagues across and beyond the department
  • Complete training to strengthen role-specific capabilities and regulatory expertise
  • Help prepare FDA cover letters and required forms
  • Develop regulatory submission plans
  • Monitor deliverable deadlines and submission components
  • Archive submission materials in designated systems
  • Provide support for regulatory submissions and related systems
  • Manage regulatory documentation
  • Monitor timelines, deliverables, and submission components
  • Respond promptly to submission updates

Requirements

  • High school diploma or equivalent
  • Communicates effectively in writing and conversation across cultures and organizational levels
  • Can independently resolve problems within the role’s responsibilities and expectations
  • Familiarity with computer systems
  • Proficiency with Microsoft Office
  • Advanced Excel and Word skills are preferred
  • Highly organized and attentive to detail
  • Demonstrated leadership ability
  • Shows initiative
  • Takes ownership of deliverables
  • Demonstrates accountability
  • Focuses on customer satisfaction
  • Experience with deliverables management
  • Knowledge of document control systems
  • Demonstrates independent thinking
  • Able to work independently
  • Project management experience is preferred
  • Must reside in the United States or Puerto Rico
  • No visa sponsorship is available; 10% travel is required.
  • benefits

Benefits

  • Annual bonus and, where applicable, long-term incentive
  • Medical, dental, and vision coverage
  • Additional insurance benefits for employees and families
  • Retirement benefits, including a 401(k) plan
  • Paid holidays
  • Vacation time
  • Compassionate and sick leave
  • Hybrid work arrangement

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