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Associate Director Regulatory Affairs Biopharma (Remote)


Executive Director


Princeton, New Jersey, United States

2015 was the year that Sandoz got approval for the first biosimilar in the United States. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar toward the future, at the same time it becomes also the right step up in your career!<br><br>The Associate Director Global Regulatory Affairs is responsible for regulatory and strategic leadership to assigned biosimilar/biotech projects. You will also be responsible to prepare, compile high quality documentation for complex global regulatory submissions in various countries. <br><br>• Provide regulatory and strategic leadership to assigned biosimilar/biotech project<br>• Represent RA on a Global Program Team (GPT) <br>• Lead a Global Regulatory (sub)team. Provide strategic input to GPT and GRS / RA team and on key HA documents<br>• Liaison with Regulatory Authorities in US and globally. <br>• Effectively address regulatory issues that may surface during regulatory reviews and prepare and facilitate preparation of responses to Authorities in various countries worldwide<br>• Responsible for development and implementation of the Regulatory Strategy and Risk Documents<br>• Ensure appropriate line function endorsement<br>• Provide regulatory and strategic input on:<br>- development concepts and documents (e.g. dev plan, CTA/IND, briefing books, dossier documents)<br>- clinical study protocols and protocol amendments<br>• Identify, review and prepare high-quality RA documentation and correspondence during development, registration and maintenance phase, to obtain rapid and advantageous approvals worldwide, while respecting agreed strategies and e-publishing requirements, besides assuring congruency and compliance<br>[#video#{#400,300#}#/video#]