Regulatory Affairs Specialist – Labelling

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Provide effective operational and regulatory support to ensure compliance and regulatory submission activities for ANZ, effective regulatory reporting on submission, HA questions and approval status and follow on activities including continuous improvement in relation to standards, templates and pro-cedures.
Regulatory Information Management (RIM) on relevant systems, trackers and databases for regula-tory submissions and commitments.
Provide support to the artwork team for global and local initiatives for the Australia and New Zealand market to allow the best possible time frame for registration and launch/supply continuity.
Partner with relevant stakeholders to assist in achieving optimal company outcomes.

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

1. Regulatory Team Support

• Prepare variation submissions, incl templates for artwork changes in partnership with the

Regulatory Affairs Submission Team in the required timeframe

• Support the creation, maintenance, and governance of artwork style guides across all marketed dosage forms, supporting private label, mature brands, biosimilar, prescription and OTC portfolios, ensuring compliance with HA requirements and internal initiatives such as QR codes and serialization
• Conduct 2nd review of artwork briefs and updates to ensure compliance with HA requirements and internal Artwork style guide prior to artwork creation by external agency
• Accountable for accurate and timely entries into various local and global databases and tracking platforms to ensure compliance and knowledge management through Regulatory Information Management (RIM), reporting, tracking of ANZ submission, approval status and post-approval commitments.
• Ensure key submission and post approval activity data provided by RA is up to date and accurate. Ongoing review of tracking metrics to identify areas of improvement.
• Assist in the review and maintenance of local WPs and SOPs to refine processes and procedures in accordance with global SOPs.
• Assist the Regulatory Affairs Department in the development and collation of dossier including processes and procedures to deliver high-quality published submissions to meet HA requirements for an effective submission.
• Ensure systems and processes are in place to enable regulatory history for all applications is traceable and regulatory documents are easy to locate
• Evaluates proposed changes and provides functional input and update for affiliate regulatory actions and impact.
• Contributes to performance tracking and KPIs of the team to deliver agreed targets and objectives and supports reporting.

• Liaison with international parent and license companies, third parties for the acquisition of documentation, information and responses to issues raised during review/evaluation. Create and maintain databank of frequently asked questions to improve dossier quality. Update RIM to enable SMEs to provide quality and timely responses to Health Authority questions.

• Contribute to the Regulatory Affairs Department initiatives e.g. process improvements, implementation of new technologies, audit readiness, digital readiness
• Provide input on future Regulatory IT projects both on a local and global basis as required.

2. Artwork Team Support

• Support the regulatory submissions team on artwork related activities with input from relevant Regulatory Affairs Associate to ensure continuity of product supply

• Creation of Artwork change requests; perform data maintenance and implementation tasks;

• liaise with internal and external stakeholders for timely implementation of updated artworks
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• Generate artwork briefs for new submissions and variations according to HA requirements and internal AW style guide

• Support RA and Artwork teams with the execution of tasks within the artwork approval system, (generating annotations, uploading documents, document review and document approval) as required

3. Other Activities

• Contribute to continuous improvement activities such as revision of SOPs/WIs

• The position will also assist the Director of Scientific Affairs or their nominee on tasks as required.

• Keep up to date with current overseas, Australian and New Zealand regulatory requirements and how these affect the Sandoz pipeline and product portfolio

• Provide strategies for internal projects, and continuous improvement via knowledge sharing.

Ways to Measure Accomplishment

• Regulatory submissions are submitted in accordance with global/local procedures. Regulatory submissions information is updated and archived in accordance with global and local filing and archiving SOP; ARTG details reflect registered details
• Demonstrate all aspects of local SOPs and related documents are practiced by the team
• Evidence of regular training on local SOPs and related documents.
• Local and global stakeholders are kept updated on progress of application, in order to support product supply as defined by customer feedback and compliance with local best practice
• Regulatory input for databases is provided to enable effective change management
• Post-approval commitments are adequately tracked, communicated, and completed
• Objectives and timelines of assigned departmental projects are met
• Active participation in departmental meetings
• Appropriate level of sharing on expertise and knowledge
• Active contribution to HA and industry consultation processes
• Develop and implement local strategies to manage regulatory risk

What you’ll bring to the role:

Essential Requirements:

• Graduate with experience in pharmaceutical industry
• Minimum of 2 years industry experience desired
• Strong attention to detail; thorough preparation of documents.
• Ability to work on multiple projects simultaneously and change direction quickly.
• Demonstrate ability to access information from multiple sources.
• Ability to support other members of the team.
• Some knowledge of TGA and Medsafe requirements.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, 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 is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!

Skills Desired

Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance