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Cmc Regulatory Assistant – France

2+ years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

CMC Regulatory Assistant – France (Full-Time, Permanent)

Excelya | Full-Time | Permanent | France

Excelya, a leading Contract Research Organization (CRO) in Europe, is seeking a CMC Regulatory Assistant to provide administrative and operational support for project managers in the Regulatory CMC Division. This role involves managing quality documentation, regulatory databases, and supporting the CMC team in ensuring compliance with global regulatory requirements.

Key Responsibilities

  • Administrative & Operational Support: Assist project managers with document preparation, formatting, correspondence, filing, and meeting organization.
  • Quality Documentation Management: Maintain and update CMC regulatory documents in internal databases.
  • Document Legalization & Notarization: Handle requests for legalization, notarization, and apostille of regulatory documents.
  • Regulatory Database Management: Ensure accurate data input and updates within internal systems.
  • Archiving & Compliance: Oversee the proper storage and organization of original documents and regulatory files.
  • Standard Assistance for Regulatory CMC Division: Coordinate travel arrangements, expense reporting, meeting scheduling, and document translation requests.
  • Division Director Support: Manage the director’s calendar, monitor signature approvals, track document progress, and facilitate access to required tools for new team members.

Minimum Requirements

  • Assistant training with at least 2 years of experience in a pharmaceutical laboratory or technical department.
  • Strong autonomy, attention to detail, organization skills, and ability to meet deadlines.
  • Problem-solving mindset with a solution-oriented approach to tasks.
  • Proficiency in Microsoft Office (Word, Excel).
  • Professional English (written and spoken).
  • Strong computer literacy and experience with regulatory systems and databases.

This role is ideal for a detail-oriented and organized professional looking to contribute to regulatory compliance in a dynamic, team-driven environment.