Regulatory Affairs Project Manager
The Regulatory Affairs Project Manager plays a critical role in leading and coordinating cross-functional regulatory projects across Australia and New Zealand. They ensure timely delivery of regulatory submissions, compliance initiatives, and strategic regulatory goals.
Key Responsibilities:
* Collaborate with local and global stakeholders to develop optimum project and regulatory strategies.
* Contribute to industry groups to drive strategic priorities and influence the regulatory environment.
* Operational excellence through use of quality systems to meet corporate and regulatory compliance requirements.
* Support people development to ensure capability and performance.
Leadership
* Contribute to industry groups to ensure clear representation of the organization's position.
* Embed best practice through collaboration and alignment with key stakeholders.
* Support recruitment and development of regulatory team members.
Regulatory Submissions
* Ensure brand plans include optimal regulatory and risk minimization strategies.
* Develop and maintain excellent relationships with health authorities.
* Monitor the regulatory environment and communicate impact to business stakeholders.
* Ensure continued regulatory compliance through maintenance of registrations.
Project Management
* Plan, execute, and monitor regulatory projects including product registrations and lifecycle management.
* Develop detailed project plans, timelines, and resource allocations.
* Manage outsource arrangements for effective delivery of projects.
Risk Management
* Implement local regulatory risk assessment procedures to manage business risk.
* Manage regulatory review of promotional/non-promotional materials.
* Ensure appropriate systems are utilized for tracking compliance.
Quality Systems
* Support maintenance of regulatory quality systems.
* Ensure audit readiness for internal audits or external audits.
Candidate Profile
Essential Skills and Experience
* At least 5 years' experience in the pharmaceutical industry.
* Knowledge of regulations in Australia and New Zealand.
* Excellent communication skills.
* History of successful engagement with regulators.
* Team orientation and sense of common good and purpose.
* Ability to work transversally in a global organization.
Desirable Skills and Experience
* Experience in project management, preferably within the pharmaceutical industry.
* Negotiation and leadership skills.
We recognize the diversity of our employees and strive for inclusivity. We respect backgrounds, experiences, and lifestyles and promote an inclusive work environment.