CMC Writer
CMC Writer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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
- 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.
- Prior experience in pharmaceutical or regulatory writing.
- CMC (Chemistry Manufacturing and Controls) Writer experience.
Employment Type
Full-time
