Summary

Internal Role Title: Regulatory Affairs Manager

Location: Sydney, Australia #LI-Hybrid

About the Role:

As Regulatory Affairs Manager you will manage, plan and coordinate submissions to health authorities in Australia and New Zealand. Reporting to Head of Regulatory Affairs, you will develop strategies to deliver optimal regulatory outcomes, ensure compliance with all local laws, regulations and company policies.. You will work closely with all internal business partners and provide strategic advice to as needed. Liaise directly with health authority personnel to enhance the company's reputation and build constructive relationships with decision-makers. As a member of senior RA leadership, you will attend relevant meetings be a contribute to all discussions impacting the department, people and organisation.

• Develop and implement broader regulatory strategies within the team. Manage team resources, assigning projects and work to direct reports. Nominate direct reports for cross-functional assignments.
• Review performance of direct reports and provide professional development as needed. Engage RA associates in BF projects for career support and training. Ensure regulatory strategies and timelines are accurately entered into relevant systems. Prepare regular reports of regulatory plans for key submissions for group discussion and communication to senior management.
• Conduct thorough risk analysis and develop effective mitigation strategies for major submissions. Contribute to key policy issues and TGA consultations.
• Maintain high RA visibility within the business. Establish effective peer relationships to advance regulatory strategies and enhance RA profile and credibility. Ensure regulatory maintenance and compliance of assigned portfolio through direct supervision of direct reports. Ensure direct reports complete all relevant training to comply with Novartis policies and procedures.
• Set up systems and processes for effective communication of key activities and issues within the team and establish escalation processes to RA Head and senior management.
• Deputise for RA Head as needed. Provide career support to direct reports and act as a mentor.
• Recognise achievements of team members and peers and how they contribute to achieving team and company goals.

• Tertiary qualification in Pharmacy, Medicine or Science (majoring in a life science), ideally with a relevant postgraduate qualification.
• Minimum 3 to 5 years' experience in a management or Team Leader role in regulatory affairs dealing with a wide variety of registration projects and regulatory issues.
• Provide professional development, coaching and growth opportunities to your teams as well as other RA associates and company personnel as needed.
• In-depth and demonstrated knowledge of the Australian and New Zealand regulatory environment and a good understanding of the overseas regulatory environment.
• Track record of successes directly due to strategic involvement in key regulatory projects.
• Developed strong and constructive working relationships with TGA and Medsafe personnel and decision-makers