Regulatory Affairs Project Manager

Purpose of Role     

Global Regulatory Affairs has a critical role to play in optimising all stages of the life cycle of our products.

Reporting to the Country Regulatory Head or Regulatory Affairs Manager ANZ, the Regulatory Affairs Project Manager is responsible for leading and coordinating cross-functional regulatory projects across Australia and New Zealand, ensuring timely delivery of regulatory submissions, compliance initiatives, and strategic regulatory goals. A patient centric approach will ensure the synergy between patient health and well-being and commercial success can be realised.

Success in this role will be achieved through:

• Collaboration with local and global stakeholders to develop optimum project and regulatory strategies to maximise business opportunities for both new product registration and ongoing life cycle management.

• Ability to support activities to influence the regulatory environment through contribution to industry groups and consultations to drive the strategic priorities.

• Operational excellence through use of necessary quality systems to meet corporate and regulatory compliance requirements for all regulatory activities in Australia and NZ.

• Support for people development to ensure capability and performance to achieve affiliate and corporate priorities.

Priorities

Leadership

• Contribute to industry groups to ensure clear representation of Sanofi position to drive an optimal regulatory environment

• Embed best practice through collaboration and alignment with key local and global stakeholders to create optimal regulatory strategies to deliver best business outcomes

• Support recruitment and development of regulatory team to achieve business priorities with an open feedback culture that ensures individual performance and accountability

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  Regulatory Submissions

  Ensure brand team plans include optimal regulatory and risk minimisation strategies through collaboration with key local and global stakeholders to provide cross functional expertise and drive early submission and approvals in accordance with agreed business priorities.

  Develop and maintain excellent relationships with health authorities to effectively negotiate timely approvals and optimal product labelling and risk minimisation strategies.

  Monitor regulatory environment to identify potential future changes and ensure impact to business is communicated to relevant local and GRA contacts.

  Ensure continued regulatory compliance through maintenance of registrations by timely submission of post-approval variations and active discontinuation of unused registrations with no portfolio value.

• Project Management

  ·Plan, execute, and monitor regulatory projects including product registrations, lifecycle management, and compliance initiatives.

  ·Develop detailed project plans, timelines, and resource allocations in alignment with regulatory priorities.

  ·Ensure outsource arrangements are managed to enable effective delivery of projects across all business units and maintenance of compliance.

• Risk Management

  Implement local regulatory risk assessment procedures to manage business risk for both new product registrations and ongoing life cycle management.

  Manage regulatory review of promotional/non promotional materials

  Ensure appropriate systems utilised for tracking compliance to meet regulatory obligations.

• Quality Systems

  Support maintenance of regulatory quality system to meet required corporate and regulatory standards.

  Ensure audit readiness for internal audits or external audits by health authorities and manage compliance with any required corrective actions.

Candidate Profile

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

• A team orientation and a sense of “common good” and “common purpose”

• Ability to work transversally in a global organisation

• Microsoft Office skills

• Presentation skills

Essential Qualifications

• Tertiary qualifications in pharmacy or life sciences

Desirable Skills and Experience

• Knowledge of local and corporate Standard Operating          Procedures

• Experience in project management, preferably within the pharmaceutical or healthcare industry.

• Knowledge of EU and FDA regulatory processes

• Active participation in Industry Working Groups

• Negotiation skills

• Leadership skills