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Cmc Regulatory Manager – France

Excelya
Excelya
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)

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

Excelya, a leading European Contract Research Organization (CRO), is looking for a CMC Regulatory Manager to oversee post-approval activities for commercial small molecule products across global markets. This role involves managing regulatory strategies, change controls, and ensuring compliance with international submission requirements.

Key Responsibilities

  • Lead the CMC regulatory strategy for post-approval activities, providing proactive guidance.
  • Manage Change Control requests, ensuring regulatory compliance.
  • Oversee project management activities for CMC post-approval submissions.
  • Liaise with local affiliates to align CMC dossiers with country-specific requirements.
  • Represent CMC Regulatory in governance meetings and strategic discussions.
  • Prepare, review, and compile regulatory documents for timely submissions.
  • Conduct gap analysis and risk management for regulatory submissions.
  • Identify rate-limiting factors and interdependencies across regulatory and technical areas.
  • Provide status updates to key stakeholders.
  • Oversee document management systems to ensure compliance and efficiency.

Minimum Requirements

  • 10+ years of experience in CMC technical roles, including at least 5 years in lifecycle management of small molecule products.
  • Proven expertise in post-approval CMC regulatory activities at a global level.
  • Strong stakeholder management skills throughout the asset lifecycle.
  • Highly organized, independent, and able to manage multiple projects simultaneously.
  • Degree in Pharmacy or a relevant technical/scientific field.
  • Fluent in English.

Location: Paris Area, France (Hybrid Remote Option Available)

This is an excellent opportunity for an experienced CMC Regulatory professional to contribute to a leading CRO and drive the successful lifecycle management of small molecule products worldwide.