FSP client dedicated Reg Affairs Specialist - Regulatory CMC (Operations) Coordinator

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.
• undefinedKey CompetenciesOrganization and PlanningAttention to DetailData AccuracyCollaboration and teamworkRegulatory Compliance AwarenessProblem solvingContinuous 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.
  
  Apply today to help us deliver tomorrow’s breakthroughs.

Welcome

Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell?

About Us

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

EEO

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.