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.
Job Type: Full-time
Pay: $30.00 - $45.00 per hour
Application Question(s):
- Prior experience authoring CMC sections for regulatory submissions (IND, NDA, BLA, or MAA)?
- Ability to write and review documents in eCTD format?
- ) Do you have prior experience authoring CMC sections for regulatory submissions (e.g., IND, NDA, BLA, or MAA)? If yes, please specify which submissions you've worked on.
- How many years of experience do you have in pharmaceutical or regulatory writing?
Education:
- Bachelor's (Required)
Work Location: In person