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Cmc Regulatory Manager – France

10+ 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 Manager – France (Full-Time, Permanent, Hybrid in Paris Area)

Excelya | Full-Time | Permanent | Paris Area (Hybrid Remote Option)

Excelya, a leading European Contract Research Organization (CRO), is looking for a CMC Regulatory Manager to lead and deliver post-approval regulatory activities for small molecule products across global markets. This role requires an experienced regulatory expert to manage lifecycle activities, regulatory submissions, and stakeholder communication to ensure compliance and efficiency.

Key Responsibilities

  • Lead CMC Regulatory Strategy for all post-approval activities, providing proactive guidance to the technical team.
  • Manage & deliver all regulatory aspects related to Change Control requests.
  • Oversee project management activities to ensure regulatory documentation is delivered on time and with high quality.
  • Work with Local Affiliates to develop efficient regulatory strategies and align CMC dossiers with country-specific requirements.
  • Represent CMC Regulatory in governance meetings and decision-making processes.
  • Write, review, and compile regulatory documents for submissions in compliance with country regulations.
  • Conduct gap analysis and provide risk management support for submissions.
  • Identify rate-limiting factors and interdependencies between technical and regulatory activities.
  • Provide status updates to internal and external stakeholders.
  • Ensure effective document management using the designated system.

Minimum Requirements

  • 10+ years of experience in CMC technical roles, with at least 5 years in post-approval lifecycle management of small molecule products.
  • Extensive experience in global CMC regulatory submissions and post-approval processes.
  • Proven ability to effectively manage stakeholders in lifecycle regulatory activities.
  • Highly organized, independent, and able to handle multiple tasks simultaneously.
  • Degree in Pharmacy, Life Sciences, or a related technical field.
  • Fluent in English (spoken & written).
  • Paris-based role with hybrid remote flexibility.

This is an exciting opportunity to join a dynamic regulatory team and play a key role in global CMC lifecycle management for small molecule products.