Pharmaceutical CMC Writer (04+Months Contract)
SUMMARY:
ā¢ 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:
ā¢ 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.
ā¢ Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions
ā¢ 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
ā¢ Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines.
ā¢ Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions.
ā¢ Assess and communicate potential regulatory risks and propose mitigation strategies
ā¢ 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.
ā¢ Identify, communicate and escalate potential CMC regulatory issues, as needed
ā¢ Help establish regulatory CMC submission processes and procedures.
ā¢ Familiar with eCTD format submission files
ā¢ Project management skill is plus
KEY RESPONSIBILITIES:
ā¢ Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications.
ā¢ Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements.
ā¢ Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data.
ā¢ Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing.
ā¢ 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:
ā¢ Prior experience in pharmaceutical or regulatory writing.
ā¢ CMC (Chemistry, Manufacturing, and Controls) Writer experience.
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ā¢ 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:
ā¢ 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.
ā¢ Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions
ā¢ 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
ā¢ Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines.
ā¢ Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions.
ā¢ Assess and communicate potential regulatory risks and propose mitigation strategies
ā¢ 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.
ā¢ Identify, communicate and escalate potential CMC regulatory issues, as needed
ā¢ Help establish regulatory CMC submission processes and procedures.
ā¢ Familiar with eCTD format submission files
ā¢ Project management skill is plus
KEY RESPONSIBILITIES:
ā¢ Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications.
ā¢ Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements.
ā¢ Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data.
ā¢ Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing.
ā¢ 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:
ā¢ Prior experience in pharmaceutical or regulatory writing.
ā¢ CMC (Chemistry, Manufacturing, and Controls) Writer experience.
Apply Now
Apply Now