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 current 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 Informat