Job Overview
We are seeking a skilled Regulatory Affairs Project Manager to lead and coordinate cross-functional regulatory projects across Australia and New Zealand.
The successful candidate will be responsible for ensuring timely delivery of regulatory submissions, compliance initiatives, and strategic regulatory goals.
A patient-centric approach will ensure synergy between patient health and well-being and commercial success.
This role will be achieved through collaboration with local and global stakeholders to develop optimum project and regulatory strategies.
Main Responsibilities
Regulatory Strategy
* Develop and implement regulatory strategies to maximise business opportunities for both new product registration and ongoing life cycle management.
* Support activities to influence the regulatory environment through contribution to industry groups and consultations.
Project Management
* Plan, execute, and monitor regulatory projects including product registrations, lifecycle management, and compliance initiatives.
* Ensure outsource arrangements are managed to enable effective delivery of projects across all business units.
Risk Management
* Implement local regulatory risk assessment procedures to manage business risk for both new product registrations and ongoing life cycle management.
Quality Systems
* Support maintenance of regulatory quality system to meet required corporate and regulatory standards.
Candidate Requirements
Essential Skills and Experience
* At least 5 years' experience in the pharmaceutical industry.
* Knowledge of regulations in Australia and New Zealand.
* Excellent verbal and written communication skills.
* History of successful engagement with regulators to achieve optimum business outcomes.
Benefits
This is an excellent opportunity for a motivated and experienced professional to make a real impact in the regulatory affairs field.
What We Offer
* A dynamic and supportive work environment.
* Opportunities for career growth and development.
* Competitive salary and benefits package.