Regulatory Affairs, Project Manager

Job Description Summary

As a key member of our regulatory affairs team, you will efficiently drive the regulatory evaluation, feasibility, strategy, and gap analysis for pipeline products to execute quality product registration for the Australia and New Zealand market.

You will also assist the Scientific Affairs Director in the leadership and development of the regulatory affairs team and provide strategic guidance to the business with your in-depth understanding of regulatory requirements.

Job Description

Your responsibilities include, but not limited to:

• 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 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.
• Drive strategic regulatory initiatives and maintain effective registration strategies for Australia and New Zealand.
• Project management of pre-submission planning, review, and submission process
• Provide support to regulatory and cross-functional teams to achieve development objectives and prioritize 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 attention to detail; thorough preparation of documents.
• Ability to work on multiple projects simultaneously and change direction quickly.
• Good ability to access information from multiple sources.
• Ability to lead and guide junior 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. assuming responsibility and accountability for successfully completing assignments or tasks.

 

Why Sandoz?
Generic and biosimilar medicines are the backbone of the healthcare industry, and Sandoz touches the lives of nearly 500 million patients globally each year. While we are proud of this impact, we are driven to do more. Through investments in development capabilities, state-of-the-art production sites, strategic acquisitions, and partnerships, we are shaping the future of affordable, high-quality medicines.

Our momentum is powered by an open, collaborative culture and a team of talented, ambitious associates. We foster an agile and inclusive environment where diversity is valued, innovation is encouraged, and personal growth is supported.

Locally, we are proud to have achieved four consecutive Great Place to Work® certifications and to be recognised as the #1 Best Workplace in Pharmaceuticals & Biotechnology in Australia for 2025.

Skills Desired

Data Analysis, Documentation Management, Lifesciences, Regulatory Compliance, Waterfall Project Management