GxPeople Global ยท 1 day ago
CMC Writer
United States
Contract
Remote
Mid, Senior Level
3+ years expGxPeople Global is seeking a skilled CMC Writer to join the Regulatory Science team of their multinational client. The role involves authoring and reviewing CMC sections of regulatory submissions and ensuring compliance with FDA guidelines.
Staffing & Recruiting
Hiring Manager
Nadia Di Meo
Responsibilities
Write and review Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions
Contribute to CMC database management in Veeva
Prepare high-quality CMC documentation in compliance with FDA and other global regulatory guidelines
Work closely with cross-functional teams, including Regulatory Science, Scientific and Regulatory Affairs, QA, R&D, and Manufacturing
Ensure accuracy, consistency, and compliance of CMC documents with regulatory standards
Stay updated on FDA regulations and guidelines
Identify and resolve issues related to CMC documentation and submission processes
Qualification
Required
Minimum of 3-5 years of experience in FDA CMC writing and regulatory submissions, with specific experience using Veeva RIM Vault (RIM Submissions)
Background in pharmaceutical sciences, chemistry, or a related field
Understanding of FDA regulatory requirements and guidelines
Proficiency in document management systems and electronic submission standards
Strong attention to detail and organizational skills
Excellent written and verbal communication skills
Ability to work effectively in a team environment and collaborate with cross-functional teams
Company
GxPeople Global
GxPeople Global provide executive search and interim solutions for Quality and Technical Operations professionals.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase