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Regulatory Process Improvement Project Manager – France

0-2 years
Not Disclosed
10 May 1, 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

Regulatory Process Improvement Project Manager – France
Slug: regulatory-process-improvement-project-manager-france-excelya

Position: Regulatory Process Improvement Project Manager
Type: Full-time, Permanent
Location: France
Company: Excelya


Why Join Excelya:
Excelya is an ambitious, people-centric healthcare company uniting 900+ professionals known as "Excelyates." Our innovative one-stop service model—encompassing full-service CRO, functional service provision, and expert consulting—offers a dynamic environment for career development and scientific impact. We’re committed to becoming Europe’s leading mid-size CRO by providing the best employee experience.


About the Role:
As the Regulatory Process Improvement Project Manager, you will drive strategic transformation initiatives within Excelya’s Regulatory function. This role focuses on optimizing operational efficiency, enhancing compliance, and embedding a culture of continuous improvement across the regulatory organization. You will collaborate cross-functionally, manage critical projects, and support the long-term success of regulatory operations.


Key Responsibilities:

  • Lead and execute process improvement initiatives across global regulatory activities throughout the product lifecycle

  • Analyze current workflows to identify inefficiencies, gaps, and improvement opportunities

  • Engage cross-functional teams to collect insights and understand operational challenges

  • Document roles, responsibilities, and process flows to create a process baseline

  • Recommend and implement optimization strategies using methodologies like Lean or Six Sigma

  • Define and track key performance indicators (KPIs) to evaluate process efficiency

  • Develop detailed project plans and manage implementation of agreed improvements

  • Facilitate change management and provide support to teams during transitions

  • Collaborate with regulatory affairs, quality, and operations teams to align priorities

  • Champion a continuous improvement culture within the regulatory department


Candidate Profile:

  • Experience: Comfortable working in fast-paced, team-oriented environments

  • Skills:

    • Strong project management capabilities

    • Background in regulatory affairs is a plus

  • Education: Pharmacist or Master’s Degree in Regulatory Affairs or equivalent

  • Languages: Professional fluency in French and English is required