Ecocareers ยท 1 month ago
Project Manager, Regulatory CMC
Paramus, NJ, NJ
Full-time
Onsite
Senior Level
5+ years expConfidential company is seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. This role combines technical writing expertise with project management skills to drive Chemistry, Manufacturing, and Controls (CMC) deliverables across drug development programs.
Staffing & Recruiting
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
Qualification
Required
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
Bachelor's or advanced degree in Chemistry, Pharmaceutical Sciences, or related field
Preferred
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
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase