CMC Regulatory Affairs Manager - Small Molecules - RAM - NavitsPartners : Job Details

Job Title: CMC Regulatory Affairs Manager - Small Molecules Location: New Brunswick, NJ (preferred) or Lawrenceville, NJ Schedule: Monday-Friday, Normal Business Hours (50% Onsite - Team onsite Monday to Thursday) Duration: 11-Month Contract Rate: $40/hr on C2C or W2 Job Description: We are seeking a CMC Regulatory Affairs Manager with a strong background in small molecule drug development to support global regulatory submissions and post-approval lifecycle management. The ideal candidate will have hands-on experience preparing regulatory documentation, a solid understanding of health authority requirements, and familiarity with Veeva systems. Top Must-Have Skills:

• 2-3 years of small molecule drug development experience
• Experience with Veeva Systems and Documentum
• Excellent communication skills (verbal and written)
• Expertise in global post-approval submissions (FDA amendments, EU variations)
• Ability to respond directly to Health Authority (HA) queries

Responsibilities:

• Contribute to the development and execution of global CMC regulatory strategies for post-approval small molecule submissions.
• Prepare, review, and compile CMC sections for global regulatory submissions (supplements, variations, responses to queries).
• Collaborate with cross-functional CMC and Regulatory teams to ensure high-quality submissions.
• Support global regulatory evaluations of CMC-related change controls.
• Stay current with international regulatory guidelines (FDA, EMA, ICH) and apply knowledge to ensure compliance.
• Participate in direct communications with Health Authorities when necessary.

Required Qualifications:

• BS/BA in a scientific discipline (Master's or higher preferred).
• 5+ years in the pharmaceutical industry, including 3+ years in CMC Regulatory Affairs.
• Preferred: Sterile Injectable experience.
• Deep understanding of FDA, EMA, and ICH regulatory frameworks.
• Experience working on global submissions, including NDAs, MAAs, ANDAs, and responses to HAs.
• Strong knowledge of post-approval requirements and lifecycle management strategies.
• Familiarity with project management tools and cross-functional collaboration.
• Detail-oriented with a solution-focused mindset and ability to manage complex regulatory projects with supervision.