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Manager, Regulatory Affairs Biosimilars (346763BR)

Management

Manager

Yearly

No

Princeton, New Jersey, United States

500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.<br><br>How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. <br><br>An exciting opportunity to join Sandoz biosimilars; an important area of drug development bringing patients affordable medicines. Manage multiple products across different therapeutic areas. Be a contributor of regulatory strategies in drug development in all phases of development, including post-approval and life-cycle management. The individual will work closely with US regulatory affairs associates.<br><br>Your responsibilities include, but are not limited to:<br>• Understands US regulations, guidance’s, and is aware of precedents: Provides input into global regulatory strategy, contributes to Regulatory Functional Plan (RFP) and Seed Document, and identifies gaps or risks<br> - Understands biosimilar, interchangeability and technical regulatory guidance’s <br> - Possibly serve as FDA liaison depending on experience<br> - Represents US Biopharmaceutical Regulatory Affairs (BRA) as a member of the regulatory sub-team to provide US regulatory guidance throughout development, launch and post-approval process<br> - Identify risk and develop mitigation plans<br><br>• Coordinates and implements regulatory readiness with other line functions<br><br>• Submissions: <br> - Responsible for coordinating US regulatory submissions, including IND, BLA, etc. product line extension application, change control and labeling supplements.<br> - Insure high quality submissions<br> - Help set up rapid response team to answer US information requests<br> - Contribute US labeling and artworks preparation<br> <br>• Executes and manages operational activities for assigned projects<br>• Contributes to development of departmental goals and objectives.<br>• Maintain compliance for assigned products (annual reports, DSURs, HA correspondence, monitor reference product label updates, adheres to SOPs<br><br><br>[#video#https://youtu.be/5_RZsoOZv5c{#400,300#}#/video#]