Senior Project Manager Heritage

JR France; Nouméa; Sur place; EUR 50 000 - 80 000; Plein temps

Résumé du poste

A large pharmaceutical company is looking for an experienced project manager for a 6-month contract. This role involves overseeing New Product Introduction efforts, ensuring regulatory compliance, and coordinating cross-functional teams for successful product launches.

Qualifications

• Strong working knowledge of cGMP and FDA regulations.
• Proven experience in regulatory submissions including NDAs.
• Understanding of global regulatory perspectives.

Responsabilités

• Lead all operational readiness efforts related to new product introduction.
• Manage and coordinate regulatory submissions and inspection readiness.
• Identify risks and develop mitigation strategies.

Connaissances

cGMP

FDA regulations

Process Analytical Technology (PAT)

regulatory compliance

Quality by Design (QbD)

Description du poste

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Client:

Blackfield Associates

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

344275914209833779232760

Job Views:

2

Posted:

09.06.2025

Expiry Date:

24.07.2025

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Job Description:

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.