R&D
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Job Title: Senior Regulatory Affairs Manager Australia & New Zealand

Location: Barangaroo, Sydney, Australia
Position Type: Permanent

About the job

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 ANZ, the Senior Regulatory Affairs Manager is responsible for helping to influence policy and developing, implementing and delivering regulatory strategies that will accelerate access to new products and optimise the value of the existing product portfolio. 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:

• Leadership to create a dynamic team culture that empowers individuals as brand team members to deliver business priorities by co-operating transversally through integrated brand planning.

• Engagement with health authorities to ensure ‘One Voice’ to develop and maintain excellent relationships and access to key stakeholders to support optimal business outcomes.

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

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

• Implementation of the necessary quality systems to meet corporate and regulatory compliance requirements for all regulatory activities in Australia and NZ.

• Investment in people development to ensure capability and performance to achieve affiliate and corporate priorities, while supporting individual professional growth.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

Leadership:

• Contribute to MRP Council to provide input on any regulatory environment/changes that may impact the business to support future planning

• Participate in industry/agency 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 setting of priorities aligned with GRA strategic direction to ensure team engagement through effective communication and involvement.

• Recruit, develop and coach regulatory team to achieve business priorities with an open feedback culture that ensures individual performance and accountability

• Conduct regular performance and development discussions in line with agreed Performance Management Process.

• Ensure all relevant staff are aware of compliance obligations.

Regulatory Strategy

• 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.

• Keep up to date with developments in regulatory affairs and ensure any required revisions to departmental systems and processes are implemented.

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 resources and outsource arrangements are managed to enable effective delivery of regulatory strategies across all human health business units and maintenance of compliance.

• Ensure appropriate systems in place for tracking compliance to meet regulatory obligations.

Quality Systems

• Ensure 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.

Health, Safety and Environment

• Contribute to the development and maintenance of a safe working environment by.

• Displaying visible leadership and commitment to building a strong safety culture for all sanofi representatives. Ensuring serious injuries remain low and active participation in proactive safety programs aiming for a continuous reduction in the rate of incidents related to unsafe practices and unsafe conditions.

• Ensure that all relevant risks associated with the functional area are assessed and thoroughly analysed before the related strategy is developed and implemented

• Provide and maintain systems of work and working environments that are safe and without risks to health.

• Provide the information, instruction, training and supervision necessary to ensure the health and safety of employees.

• Consult with employees about HSE matters so that they can contribute to decisions affecting their health, safety and welfare.

• Ensure the health and safety of people visiting or working who are not employees by not exposing them to risk.

• Comply with corporate and legal health and safety requirements.

• Immediately notify any serious incidents.

• Undertake duties in accordance with the current Sanofi Policies and Procedures.

About you

• Experience: Strong Regulatory Affairs experience within the pharmaceutical or biotechnology industry, including regulatory submissions and lifecycle management

• Experience working with TGA and/or Medsafe regulatory processes and health authority interactions

• Strong stakeholder management and cross-functional collaboration skills within matrix environments

• Ability to independently manage complex regulatory activities with a strategic and execution-focused mindset

• Leadership experience managing, mentoring, or coaching team members

• Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related scientific discipline

• Excellent communication and relationship-building skills

Why choose us?

• Work in a highly visible regulatory leadership role supporting innovative therapies across the ANZ market

• Collaborate with global teams and contribute to strategic regulatory initiatives with real patient impact

• Be part of an R&D-driven, AI-powered biopharma organization focused on transforming healthcare

• Grow your career through cross-functional collaboration, international exposure, and development opportunities

• Join a flexible hybrid working environment designed to support both professional and personal growth

• Work alongside experienced leaders and teams committed to innovation, inclusion, and continuous learning

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