Pharmaceutical CMC Writer

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).