Job description
Job Summary:
We are seeking an experienced Regulatory CMC Technical Writer to support the development of high-quality Chemistry, Manufacturing, and Controls (CMC) documentation for Investigational New Drug (IND) and Investigational Medicinal Product Dossier (IMPD) submissions for small molecule pharmaceutical products. The successful candidate will collaborate cross-functionally to generate regulatory content aligned with current FDA, EMA, and ICH guidelines, and ensure consistency, clarity, and scientific rigor in submission documents.
Key Responsibilities:
Prepare, write, and review CMC sections of global regulatory submissions (INDs, IMPDs, CTAs), including Module 3 of the CTD.
Review and summarize comparability protocols and technology transfer protocols for regulatory filings.
We are seeking an experienced Regulatory CMC Technical Writer to support the development of high-quality Chemistry, Manufacturing, and Controls (CMC) documentation for Investigational New Drug (IND) and Investigational Medicinal Product Dossier (IMPD) submissions for small molecule pharmaceutical products. The successful candidate will collaborate cross-functionally to generate regulatory content aligned with current FDA, EMA, and ICH guidelines, and ensure consistency, clarity, and scientific rigor in submission documents.
Key Responsibilities:
Prepare, write, and review CMC sections of global regulatory submissions (INDs, IMPDs, CTAs), including Module 3 of the CTD.
Review and summarize comparability protocols and technology transfer protocols for regulatory filings.
- Write process development history sections by collaborating with SMEs (e.g., Process Development, Manufacturing, QA, Analytical) to cohesively describe changes from Phase 1 to Phase 3.
- Interpret and summarize analytical methods, method validation data, and stability data for inclusion in regulatory documentation.
- Draft comprehensive stability summaries by critically reviewing and interpreting available stability data across multiple batches and storage conditions.
- Create and format specification tables, batch analysis tables, and other data-driven content using Certificates of Analysis (CoAs) and internal specifications.
- Work within Veeva Vault (or similar systems) to extract data, manage versions, and author documents in alignment with document control and submission timelines.
- Ensure all regulatory content is scientifically accurate, consistent, and aligned with applicable FDA, EMA, and ICH guidelines for investigational and late-stage clinical submissions.
- Contribute to response strategies and author responses to Health Authority questions related to CMC topics.