Summary
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.
About the Role
Key Responsibilities :-
- 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.
Essential Requirements
- 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
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
