JOB TITLE: REGULATORY STUDIO CMS SENIOR MANAGER

Work Location: New Brunswick, NJ (preferred) or Lawrenceville, NJ
Work Schedule: Monday to Friday, normal business hours with some flexibility
Onsite Requirement: 50% onsite; team generally works onsite Monday–Thursday
Contract Duration: 11 Months
Pay Rate: $40.76/hour (W2)

TOP SKILLS REQUIRED:

• 2–3 years of small molecule drug development experience
• CMC regulatory experience (3+ years preferred)
• Familiarity with Veeva Vault and Documentum systems
• Strong knowledge of post-approval global submissions
• Experience preparing responses to Health Authority (HA) queries

MINIMUM QUALIFICATIONS:

• BS/BA degree in a scientific discipline (Master’s or higher preferred)
• 5+ years of experience in the pharmaceutical industry
• 3+ years of CMC Regulatory experience
• Experience with sterile injectables is preferred

REQUIRED SKILLS & KNOWLEDGE:

• Proficiency in preparing CMC regulatory documents for global markets (NDA, MAA, ANDA, IND)
• Deep understanding of FDA, EMA, and ICH regulatory guidelines
• Demonstrated experience with post-approval regulatory activities
• Strong project management skills
• Ability to contribute to CMC regulatory strategy development
• Effective communication and interpersonal skills
• Excellent attention to detail and organizational ability
• Strong technical writing and documentation skills

• Support development of CMC regulatory strategies for post-approval small molecule products
• Prepare and review global regulatory submissions including supplements/variations and HA responses
• Collaborate cross-functionally with Regulatory Affairs and CMC functional teams
• Review and evaluate global CMC change controls under supervision
• Stay current on regulatory requirements, guidelines, and policies
• Develop high-quality CMC documentation for submission, aligned with HA expectations
• Maintain accurate and updated documentation using content management systems (Veeva, Documentum)