CMC Writer

About the job CMC Writer

SUMMARY :

A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents related to drug development, manufacturing, and quality control.

JOB DESCRIPTION :

Authors a range of clinical documents, including regulatory documents following defined templates, NDA / MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.

Support the coordination and preparation of timely CMC file for AR / DSUR / RTQ submissions

Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions

Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines.

Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions.

Assess and communicate potential regulatory risks and propose mitigation strategies

Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications.

Identify, communicate and escalate potential CMC regulatory issues, as needed

Help establish regulatory CMC submission processes and procedures.

Familiar with eCTD format submission files

Project management skill is plus

KEY RESPONSIBILITIES :

Regulatory Documentation :

Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications.

Compliance & Guidelines :

Ensure documents align with FDA, EMA, and ICH regulatory requirements.

Collaboration :

Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data.

Quality Assurance :

Maintain consistency, clarity, and accuracy in technical writing.

Process Improvement :

Help establish regulatory CMC submission processes and procedures.

QUALIFICATIONS : Education :

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

Experience :

Prior experience in pharmaceutical or regulatory writing.

CMC (Chemistry, Manufacturing, and Controls) Writer experience.