Regulatory CMC Writer
Katalyst CRO · Hackensack, NJ · 6 mo ago
On-siteMarketingContract
Key Responsibilities
- Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format.
- Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals.
- Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions.
- Ensure compliance with FDA, EMA, and ICH guidelines and internal processes.
- Collaborate with cross-functional teams to gather accurate technical information.
- Identify and communicate potential regulatory risks; propose mitigation strategies.
- Support process improvement initiatives for CMC submission workflows.
Experience
- Minimum 5 years in pharmaceutical regulatory writing or CMC project management.
- Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities.
- Familiarity with global regulatory frameworks and eCTD submissions.
- Excellent technical writing, communication, and organizational skills.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint).
- Veeva Vault, Smartsheet are plus.
Preferred Skills
- Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings.
- Ability to interpret and apply regulatory guidelines effectively.
- Strong project management and stakeholder communication skills.
Education
- Bachelor's or advanced degree in Chemistry, Pharmaceutical Sciences, or related field.