Velia Multi Services ยท 2 weeks ago
CMC Writer
Paramus, NJ
Contract
Onsite
Senior Level
5+ years expVelia Multi Services 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.
Management Consulting
Responsibilities
Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions
Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions
Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines
Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions
Assess and communicate potential regulatory risks and propose mitigation strategies
Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications
Identify, communicate and escalate potential CMC regulatory issues, as needed
Help establish regulatory CMC submission processes and procedures
Familiar with eCTD format submission files
Project management skill is plus
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
Education: Bachelors or advanced degree in Chemistry, Pharmaceutical Sciences, or related field
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)
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
Veeva Vault, Smartsheet are plus
Company
Velia Multi Services
At Velia Multi Services, our mission is to elevate the hiring experience by connecting organizations with exceptional talent through a thoughtful, relationship, driven approach.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase