Job Description 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). Show more Numbers & Facts Location Paramus, NJ Salary $45–$49 Per Hour
Skills
Accounts Receivableunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Brochuresunmatched
Chemistryunmatched
Code of Federal Regulationsunmatched
Cross-Functionalunmatched
Data Collectionunmatched
Detail Orientedunmatched
Drug Developmentunmatched
Drug Manufacturingunmatched
FDA (Food and Drug Administration)unmatched
GMP (Good Manufacturing Practices)unmatched
ICH Regulationsunmatched
Interpret Regulationsunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Marketing Authorization Application (MAA)unmatched
Pharmacyunmatched
Process Improvementunmatched
Project/Program Managementunmatched
Quality Assuranceunmatched
Quality Controlunmatched
Regulationsunmatched
Regulatory Submissionsunmatched
Research & Development (R&D)unmatched
Risk Managementunmatched
Standard Operating Procedures (SOP)unmatched
Technical Writingunmatched
Writing Skillsunmatched
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