RA Project Manager

Johnson & Johnson

RA Project Manager at Johnson & Johnson leading regulatory strategies for DePuy Synthes in Australia and New Zealand. Overseeing project plans and regulatory submissions to ensure compliance and support business growth.

Posted 7/30/2026full-timeAuckland • 🇳🇿 New ZealandMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs and Project Management, with a strong focus on managing regulatory timelines and cross-functional deliverables in compliance with TGA and Medsafe requirements. Proficient in mentoring and providing technical support to teams while ensuring alignment with global regulatory strategies.

Highest-signal resume keywords

Regulatory Affairs ManagementRegulatory Project ManagementTGA ComplianceMedsafe ComplianceCross-Functional Coordination

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRisk AssessmentRegulatory Timelines ManagementProject PlanningRegulatory Operations

Soft Skills

MentoringCommunicationProblem-SolvingCollaboration

Tools & Technologies

Regulatory Project Management ToolsMetrics Tracking Systems

Industry Keywords

Medical DevicesPharmaceuticalsCombination ProductsANZ Regulatory Frameworks

About the role

Key responsibilities & impact

Lead and manage regulatory project plans for new product introductions, renewals, and lifecycle changes across Australia and New Zealand.
Coordinate cross-functional regulatory activities with local, regional, and global partners (RA, R&D, Clinical, Medical, Quality, Supply Chain, Marketing).
Develop and maintain detailed regulatory timelines, risk assessments, and status reporting to ensure on-time delivery.
Prepare, compile, and support regulatory submissions and responses to health authority questions in accordance with TGA and Medsafe requirements.
Serve as the primary regulatory project contact for assigned ANZ initiatives, proactively identifying risks and mitigation strategies.
Ensure alignment of local regulatory execution with global regulatory strategies and company objectives.
Track and manage regulatory commitments, post-market changes, and license maintenance activities.
Support continuous improvement of regulatory project management processes, tools, and metrics within QARA International.
Mentoring and technical support to Regulatory Affairs associates as required.

Requirements

What you’ll need

5+ years of experience in Regulatory Affairs, Regulatory Operations, or Regulatory Project Management within medical devices, pharmaceuticals, or combination products.
Demonstrated experience managing regulatory timelines and cross-functional deliverables.
Working knowledge of ANZ regulatory frameworks (TGA and Medsafe).
Ability to manage multiple projects simultaneously in a matrixed, global environment.
Bachelor’s degree in a scientific, engineering, or health-related discipline (e.g., Biomedical Engineering, Life Sciences, Pharmacy).
Language: Fluent English (written and verbal).

Benefits

Comp & perks

Competitive remuneration package.
Continuous training and support.
Award-winning leadership development programs.
Inclusive, flexible, and accessible working arrangements.
Equal opportunity employer supporting diversity and inclusion.