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).