Senior Project Manager

JR France; Nouméa; Sur place; EUR 60 000 - 85 000; Plein temps

Résumé du poste

JR France, a large pharmaceutical company, is seeking an experienced Project Manager for a 6-month contract. The successful candidate will be accountable for the operational readiness of a new product launch, overseeing NPI processes and regulatory submissions, working with multidisciplinary teams to ensure compliance and efficiency.

Qualifications

• Strong knowledge of cGMP and FDA regulations.
• Experience in regulatory submission processes (NDAs, MAAs).
• Familiar with ICH Q8 to Q11 standards.

Responsabilités

• Lead operational readiness efforts related to NPI.
• Manage regulatory submissions and inspection readiness activities.
• Identify risks associated with product launches and develop mitigation strategies.

Connaissances

cGMP

FDA regulations

Process Analytical Technology (PAT)

Process Performance Qualification (PPQ)

Quality by Design (QbD)

Description du poste

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We are looking for an experienced project manager to join a large pharmaceutical company on an initial 6-month contract.

This position is accountable for ensuring comprehensive operational preparedness ahead of the commercial launch of a new product . You will oversee and integrate all New Product Introduction (NPI) efforts, including l aunch execution, readiness planning, and development of product and process strategies , in collaboration with cross-functional teams at both the site level and corporate functions.

Key Responsibilities:

• Lead all operational readiness efforts related to NPI (process and analytical), working with multidisciplinary teams across Manufacturing, Engineering, Quality, MSAT, Supply Chain, and CMC.
• Manage and coordinate regulatory submissions and inspection readiness activities , including Pre-Approval Inspections (PAI) .
• Proactively identify potential risks associated with new product launches and develop strong mitigation strategies to support successful Process Performance Qualification (PPQ) and ensure stable, compliant commercial production.

Technical Expertise Required:

• Strong working knowledge of cGMP , FDA regulations , and international pharmaceutical manufacturing and quality standards .
• Proven experience applying Process Analytical Technology (PAT) , ASTM standards , and 21st Century cGMP principles.
• Familiarity with ICH Q8, Q9, Q10, and Q11 , and their application in a regulated environment.
• Experience with CMC and regulatory submission processes , including NDAs and MAAs .
• Understanding of differing global regulatory perspectives on Quality by Design (QbD) and their impact on regulatory strategy and submissions.
• Broad knowledge of regulatory compliance , validation , and inspection readiness .
• In-depth understanding of product development lifecycles , cross-functional development teams, and project governance processes.