Job Description Summary
Role Summary:
As a key member of our regulatory affairs team, you will efficiently drive the regulatory feasibility, strategy, and gap analysis for pipeline products to execute quality product registration for the Australia and New Zealand market.Job Description Regulatory Affairs Project Manager Sandoz is going through an exciting and transformative period as a global market leader in Generics and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
About the role: As a key member of our regulatory affairs team, you will efficiently drive the regulatory feasibility, strategy, and gap analysis for pipeline products to execute quality product registration for the Australia and New Zealand market.
Reporting to the Director, Scientific Affairs you will contribute to the leadership and development of the regulatory affairs team and provide strategic guidance to the business with your in-depth understanding of regulatory requirements.
Your responsibilities include, but not limited to: Drive strategic regulatory initiatives to shape the portfolio mix of product pipeline through effective registration strategies for Australia and New Zealand.Project management of pre-submission planning, review, and submission process.In collaboration with key stakeholders, establish a robust framework for managing and submitting high quality global Health Authority (HA) submissions.Advise project teams on technical submission requirements and develop strategies to address and influence evolving HA requirements.Enhance compliance and process efficiencies in global submission preparation standards.Ensure global cross-functional business/ external partners adhere to submission/ document standards and operating procedures.Ensure timely completion of new product registrations and life cycle management activities.Review registration dossiers, address deficiencies, and drive continuous improvement initiatives in consultation with TGA and other HA.Provide support to regulatory and cross-functional teams to achieve development objectives and prioritise business critical projects.Commitment to Diversity & Inclusion: Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you'll bring to the role: Strong project management skills with attention to detail; influence key stakeholders, identify and effectively communicate risks and dependencies.Ability to work on multiple projects simultaneously and change direction quickly.Demonstrated ability to access information from multiple sources.Ability to lead and guide members of the team.Expert knowledge of TGA and Medsafe requirements.Strong Collaborator and Communicator, able to give concise, accurate and constructive feedback.Set high standards of performance for self and others, ensuring responsibility and accountability for successfully completing assignments or tasks.Why Sandoz? Generic and Biosimilar medicines are the backbone of the medicines industry. Sandoz touches the lives of almost 500 million patients every year worldwide and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious associates in an agile and collegiate environment where diversity is welcomed and where personal growth is encouraged!
As part of our commitment to our culture locally we are proud to be certified and recognised as a Great Place to Work employer for the second year in a row. In addition to this, in 2023 we were listed as one of the top 50 Australian companies on the Great Place to Work for Women 2023 list.
The future is ours to shape!
#Sandoz
Skills Desired
Data Analysis, Documentation Management, Lifesciences, Project Management, Regulatory Compliance
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