Pharmaceutical CMC Writer (04+Months Contract)

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. Apply Job! Apply to this Job