Pharmaceutical CMC Writer

Job Summary

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).