Senior Regulatory Affairs Manager

4w4 weeks ago

Sanofi

AU · Full-time · A$150,000 – A$180,000

About this role

As Senior Regulatory Affairs Manager for Australia & New Zealand, you will lead the development and execution of regulatory strategies that accelerate patient access to innovative medicines. Reporting to the Country Regulatory Head ANZ, you will influence policy and optimise the value of our existing product portfolio.

Your day-to-day work involves shaping regulatory plans through cross-functional collaboration with local and global stakeholders. You will engage with health authorities to maintain excellent relationships and ensure 'One Voice' representation, while also contributing to industry groups to drive strategic priorities.

You will lead a dynamic team culture that empowers individuals as brand team members to deliver business priorities. By embedding best practices and aligning with integrated brand planning, you will help maximise opportunities for both new product registration and lifecycle management.

Sanofi invests in your professional growth through an open feedback culture that supports regular performance and development discussions. You will have the chance to influence the regulatory environment at a global level and work within an R&D-driven, AI-powered biopharma company committed to improving lives.

Requirements

Proven experience in regulatory affairs within the pharmaceutical or biopharmaceutical industry
Strong leadership capability to build and empower a dynamic team culture focused on business priorities
Ability to develop and maintain excellent relationships with health authorities and key stakeholders
Strategic thinking to create optimal regulatory strategies balancing patient access and commercial success
Experience influencing regulatory policy through contributions to industry groups and consultations
Knowledge of quality systems and compliance requirements for regulatory activities in Australia and New Zealand
Excellent collaboration skills to work transversally across brand teams and global functions

Responsibilities

Develop and implement regulatory strategies for new product registration and lifecycle management in Australia and New Zealand
Engage with health authorities to represent Sanofi with a ‘One Voice’ approach and build key stakeholder relationships
Contribute to industry and agency groups to shape an optimal regulatory environment and drive strategic priorities
Lead brand team integration through cross-functional collaboration and alignment with local and global stakeholders
Implement quality systems to meet corporate and regulatory compliance requirements for all regulatory activities
Recruit, develop, and coach the regulatory team to achieve business priorities with an open feedback culture
Conduct regular performance and development discussions in line with the agreed Performance Management Process
Set team priorities aligned with Global Regulatory Affairs strategic direction and ensure effective communication

Benefits

Investment in people development and professional growth through regular performance discussions
Dynamic team culture that empowers individuals and fosters an open feedback environment
Opportunity to influence the regulatory environment at both local and global levels
Work within an R&D-driven, AI-powered biopharma company committed to improving lives