Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Regulatory Affairs Specialist - Regulatory CMC (Operations) Coordinator - Make an Impact at the Forefront of Innovation
The Regulatory Affairs Specialist - Regulatory CMC (Operations) Coordinator provides operational and administrative support to the Regulatory CMC team to ensure timely, accurate, and inspection-ready preparation of Chemistry, Manufacturing and Controls (CMC) documentation for global and local regulatory submissions. This role works closely with Regulatory CMC Leads, Regulatory Operations, Quality, and external partners to coordinate submission content, maintain regulatory records, support dossier preparation activities, and ensure compliance with internal processes and regulatory requirements.
The Regulatory Affairs Specialist also provides administrative support to the department, including management and maintenance of regulatory documents, tools, and websites.
Key Responsibilities
Submission & Dossier Support
•Support compilation and maintenance of IMPDs, including preparation of redline versions.
•Assist with the creation of CMC-specific questions in the electronic Document management System (RIMAS) and for Clinical Trial Applications (CTAs).
•Draft CMC response documents, cover letters, forms, and other submission-related administrative documents.
•Create and maintain CMC submission content plans to support submission planning and document tracking.
•Prepare CMC manufacturing operations and manufacturing parameter data within RIMS.
•Ensure CMC documents are in an electronic submission-ready format (eSub-ready) e.g., facility information, floor plans, supporting documents.
•Assist with QC of submission output for Module 3 and Module 2.3.
Document Management & Compliance
•Create and maintain master IMPD binders and country-specific IMPD binders.
•Maintain tracking of GMP certificates, Manufacturing Import Authorizations (MIAs) including apostilled versions.
•Facilitate literature procurement and organization of supporting references required for submissions.
Data & Systems Coordination
•Perform reviews of registration data and active dossier information to identify discrepancies and missing information.
•Coordinate with Regional CMC Leads to facilitate timely review and approval of assigned workflows and data updates.
•Support maintenance of regulatory information and metadata within RIMAS and other regulatory systems.
•Collaborate with Regulatory Operations to reconcile CMC submission trackers with RIMS submission events and records.
•Assist in ensuring consistency and accuracy between regulatory planning tools and submission databases.
Preferred Qualifications
•Bachelor's degree in Life Sciences or a related field.
•Experience supporting CMC regulatory submissions and/or Clinical Trial Applications.
•Familiarity with IMPDs, CTAs, GMP documentation, and regulatory document management processes.
•Experience with AI and comfortable operating in AI-enabled environments.
•Experience with electronic document management systems such as Veeva RIM or similar platforms.
•Knowledge of electronic submission requirements and document publishing standards.
•Experience with eCTD or other electronic submission environments.
Key Competencies
Organization and Planning, Attention to Detail, Data Accuracy, Collaboration and teamwork, Regulatory Compliance Awareness, Problem solving, Continuous Improvement
Working Conditions and Environment
•Work is performed in an office or clinical environment with exposure to electrical office equipment.
•Occasional drives to site locations. Potential occasional travel required.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
