Associate Director, Regulatory Affairs - Labeling: Job ID - 1297CA

July 13

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Ascendis Pharma

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We've got making a difference for patients down to a science

Endocrinology • Oncology • Drug Development • Innovation • Globalization

501 - 1000

Description

• Responsible for labeling activities across programs and stages of development • Ensure compliance with US regulatory requirements for labeling • Coordinate internal labeling activities and processes for regulatory submissions and product maintenance • Prioritize work to meet agreed timelines independently and in a team environment • Plan, support, and advise on liaising with regulatory agencies • Develop project timelines and manage labeling projects from initiation to completion • Contribute to the development of key labeling processes and infrastructure • Ensure consistency and alignment with global labeling managers

Requirements

• BS/BA or equivalent degree in a Scientific Discipline • Regulatory experience of at least 8 years, and at least 3 years direct experience with labeling in the US • Solid knowledge of regulatory labelling requirements in the US • Experience working in international teams • Excellent collaboration and communication skills • Preference for creative thinking and solution development • Ability to interact cross-functionally with members of commercial, legal, safety, medical, and others • Proficient in document editing including Microsoft office applications (Word, PowerPoint, Excel) • Experience in systems (e.g. document management systems, labeling systems, etc.) • Recognize when to provide labeling guidance to various teams • Strong understanding of applicable labeling regulations and guidance • Responds well to challenging situations • Ability to travel up to 10% of the time domestically and internationally

Benefits

• Medical insurance • Vision insurance • Dental insurance • 401(k) • Paid maternity leave • Paid paternity leave • Commuter benefits • Disability insurance