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Pharmaceutical CMC Writer

Macpower Digital Assets Edge Private Limited

Paramus, NJ

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JOB DETAILS
SALARY
$45–$49 Per Hour
SKILLS
Accounts Receivable, Biology, Biotech and Pharmaceutical, Brochures, Chemistry, Code of Federal Regulations, Cross-Functional, Data Collection, Detail Oriented, Drug Development, Drug Manufacturing, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), ICH Regulations, Interpret Regulations, Maintain Compliance, Manufacturing, Marketing Authorization Application (MAA), Pharmacy, Process Improvement, Project/Program Management, Quality Assurance, Quality Control, Regulations, Regulatory Submissions, Research & Development (R&D), Risk Management, Standard Operating Procedures (SOP), Technical Writing, Writing Skills
LOCATION
Paramus, NJ
POSTED
9 days ago
Job Summary: A CMC (Chemistry, Manufacturing, and Controls) Writer prepares and reviews technical documents for regulatory submissions, ensuring compliance with FDA (IND/BLA/NDA), EMA (IMPD/MAA), and ICH guidelines. This role bridges drug development, manufacturing, and quality control to deliver high-quality eCTD submissions.
Key Responsibilities:
Regulatory Documentation & Submissions:
  • Author/review CMC sections of regulatory dossiers (eCTD Module 2.3 & 3) for US-FDA (IND, BLA, NDA) and EU (IMPD, MAA).
  • Support DSUR, AR, RTQ, and Investigator Brochures; respond to health authority queries.
  • Ensure submissions adhere to FDA/EMA/ICH guidelines and internal SOPs.
Compliance & Risk Management:
  • Identify/escalate CMC regulatory risks and propose mitigation strategies.
  • Interpret regulations (e.g., GMP, ICH Q7/Q11) to guide cross-functional teams.
Collaboration & Process Improvement:
  • Work with R&D, Manufacturing, and QA/QC to compile accurate data.
  • Help establish CMC submission processes and templates.
Qualifications & Skills:
Must-Have:
  • Bachelor's/Master's in Chemistry, Pharmacy, or Life Sciences.
  • 2+ years authoring CMC sections (IND/NDA/BLA/MAA).
  • Expertise in eCTD formatting and CTD structure (Modules 2.3, 3.2.S/P).
  • Knowledge of FDA 21 CFR, EMA GMP, and ICH guidelines.
  • Strong technical writing, attention to detail, and cross-functional collaboration.
Nice-to-Have:
  • Project management (timelines, stakeholder coordination).
  • Experience with post-approval changes (variations, supplements).

About the Company

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Macpower Digital Assets Edge Private Limited

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