CMC Regulatory Writer — Cell Therapy Submissions

Integrated Resources, Inc ( IRI ); New Brunswick (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

Integrated Resources, Inc (IRI) is seeking a Technical Writer and Document Specialist to support regulatory strategy in Cell Therapy Development. This role entails co-authoring scientific content, managing regulatory submissions, and collaborating with cross-functional teams.

The ideal candidate must have a Bachelor's in Biology or related discipline, with at least 2 years’ experience in regulatory documentation and familiarity with biotechnology. The role offers an opportunity to work independently while supporting continuous process improvements.

Qualifications

• Minimum of 2 years’ experience (4-7 years for senior level).
• Familiarity with regulatory requirements for CMC documentation.
• Experience in bio tech/pharma e2e product development.

Responsibilities

• Co-author scientific content for regulatory submissions.
• Manage the logistical process for submissions.
• Ensure content clarity and consistency across dossiers.

Skills

Regulatory submissions

Technical writing

Project management

Collaboration

Biotechnology knowledge

Education

Bachelor’s degree in Biology or related discipline

Tools

Microsoft Office

eCTD structure

Job description

Integrated Resources, Inc (IRI) is seeking a Technical Writer and Document Specialist to support regulatory strategy in Cell Therapy Development. This role entails co-authoring scientific content, managing regulatory submissions, and collaborating with cross-functional teams.

The ideal candidate must have a Bachelor's in Biology or related discipline, with at least 2 years’ experience in regulatory documentation and familiarity with biotechnology. The role offers an opportunity to work independently while supporting continuous process improvements.