Talent Search PRO
CMC Writer with Pharmaceutical or Regulatory Writing Exp
Talent Search PRO, Paramus, New Jersey, us, 07653
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 elevate 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.
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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 elevate 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.
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