Senior Manager, Regulatory Operations- Job ID: 1070ADN at Ascendis Pharma

We are a small company that values teamwork and prioritizes employee well-being. We are seeking a Regulatory Operations Senior Manager to assist with daily operational activities for regulatory submissions, timeline management, and archival activities. The Senior Manager will report directly to the Director of Regulatory Operations. The role involves managing the preparation of regulatory submissions, leading electronic publishing efforts, collaborating with Regulatory Affairs and other functional areas, preparing documents for submissions, and providing support for Veeva RIM systems. The ideal candidate should have a college degree and at least 6 years of relevant experience in the pharmaceutical and/or biotechnology industries. Strong knowledge of technical requirements for electronic submissions and proficiency in Microsoft Office Suite and Adobe Acrobat are required. Travel may be required up to 5% of the time domestically and internationally. New hires in the US must be fully vaccinated for COVID-19 or qualify for an exemption or accommodation. Responsibilities: - Assist in managing daily operational activities for preparation of regulatory submissions - Lead electronic publishing efforts for electronic submissions to regulatory agencies - Collaborate with Regulatory Affairs and other functional areas to create submission project plans and timelines - Prepare documents for submissions in eCTD format or paper submission - Interface with publishing vendors to ensure compliant electronic submissions - Support the use of templates and guidelines for regulatory submissions - Provide expertise in regulatory and technical submission requirements - Provide 1st tier support for Veeva RIM systems

Senior Manager, Regulatory Operations- Job ID: 1070ADN

Responsibilities

Skills wanted:

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About Ascendis Pharma:

mission:

ascendispharma.com

Admin access needed