CMC Regulatory Affairs Manager - Small Molecules - RAM 25-27040

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

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.

• 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

• 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.

• 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.