Regulatory CMC Writer — Drug Submissions Expert

5 Star Recruitment; Paramus (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading recruitment firm is seeking an experienced Pharmaceutical CMC Writer in Paramus, New Jersey. The candidate will play a critical role in preparing technical documents related to regulatory submissions for drug development and manufacturing. Responsibilities include authoring clinical documents, ensuring regulatory compliance, and collaborating with scientific teams. Candidates should possess a relevant degree and prior experience in pharmaceutical or regulatory writing.

Qualifications

• Experience in pharmaceutical or regulatory writing.
• Familiarity with CMC submission processes and procedures.

Responsibilities

• Author and review CMC sections of regulatory submissions.
• Ensure compliance with FDA, EMA, and ICH regulations.
• Work closely with scientists and manufacturing experts.

Skills

Regulatory writing

Technical document preparation

Project management

Understanding of FDA/EMA guidelines

Collaboration with teams

Education

Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or related field

Job description

A leading recruitment firm is seeking an experienced Pharmaceutical CMC Writer in Paramus, New Jersey. The candidate will play a critical role in preparing technical documents related to regulatory submissions for drug development and manufacturing. Responsibilities include authoring clinical documents, ensuring regulatory compliance, and collaborating with scientific teams. Candidates should possess a relevant degree and prior experience in pharmaceutical or regulatory writing.