Regulatory Studio CMS Senior Manager - RSCMSSM VG #2

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

Key Responsibilities:

• 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)

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

Nice to Have (Preferred):

• Direct experience with initial submissions (NDA, MAA, ANDA, IND)

• Experience coordinating directly with Health Authorities

• Exposure to global regulatory landscapes for marketed products

• Background working on complex regulatory projects involving cross-functional collaboration