Ascendis Pharma A/S
Associate Director, Regulatory Affairs, Labeling - Job ID: 1297NJ
Ascendis Pharma A/S, Princeton, New Jersey, us, 08543
Ascendis Pharma is
a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.Guided by our core values of Patients, Science, and Passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for:Labeling activities across programs and stages of development, specifically for the United States and the Americas, while supporting global needs as required.Ensuring compliance with US regulatory requirements for labeling and coordinating internal labeling activities and processes for regulatory submissions and product maintenance.Prioritizing work to meet agreed timelines and working both independently and in a team environment.Global coordination and collaboration with external partners as needed.Key responsibilities:Drive process for development and management of US & Americas labeling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy.Provide labeling advice and expertise on Company Core Data Sheet (CCDS), USPI, and Canadian Monograph content, collaborating with market leads to develop local labeling in line with global strategies and local regulations.Coordinate US labeling activities for regulatory submissions, product maintenance, and safety variations, including developing timelines, involving relevant SMEs, and handling reviews.Understand and interpret regulatory requirements for labeling to meet applicable regulations.Perform global label competitive intelligence and make recommendations for actions.Plan, support, and advise in liaison and negotiation with FDA and other agencies as needed for labeling content.Ensure and maintain tracking and archiving of approved labels.Develop project timelines and manage labeling projects from initiation to completion.Contribute to the development of key labeling processes and infrastructure.Work closely with global labeling managers to ensure consistency and alignment.Minimum Requirements:BS/BA or equivalent degree in a Scientific Discipline; advanced degree desirable.Regulatory experience of at least 8 years, with at least 3 years of direct experience with labeling in the US.Solid knowledge of regulatory labeling requirements in the US and an understanding of current global and regional trends.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.).Strong understanding of the purpose of the Target Product Label and CCDS and the associated implications on labeling globally.Participates with influence in or leads departmental and cross-functional taskforces and initiatives.Ability to travel up to 10% of the time domestically and internationally.Estimated compensation: $180-200K/year
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a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.Guided by our core values of Patients, Science, and Passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for:Labeling activities across programs and stages of development, specifically for the United States and the Americas, while supporting global needs as required.Ensuring compliance with US regulatory requirements for labeling and coordinating internal labeling activities and processes for regulatory submissions and product maintenance.Prioritizing work to meet agreed timelines and working both independently and in a team environment.Global coordination and collaboration with external partners as needed.Key responsibilities:Drive process for development and management of US & Americas labeling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy.Provide labeling advice and expertise on Company Core Data Sheet (CCDS), USPI, and Canadian Monograph content, collaborating with market leads to develop local labeling in line with global strategies and local regulations.Coordinate US labeling activities for regulatory submissions, product maintenance, and safety variations, including developing timelines, involving relevant SMEs, and handling reviews.Understand and interpret regulatory requirements for labeling to meet applicable regulations.Perform global label competitive intelligence and make recommendations for actions.Plan, support, and advise in liaison and negotiation with FDA and other agencies as needed for labeling content.Ensure and maintain tracking and archiving of approved labels.Develop project timelines and manage labeling projects from initiation to completion.Contribute to the development of key labeling processes and infrastructure.Work closely with global labeling managers to ensure consistency and alignment.Minimum Requirements:BS/BA or equivalent degree in a Scientific Discipline; advanced degree desirable.Regulatory experience of at least 8 years, with at least 3 years of direct experience with labeling in the US.Solid knowledge of regulatory labeling requirements in the US and an understanding of current global and regional trends.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.).Strong understanding of the purpose of the Target Product Label and CCDS and the associated implications on labeling globally.Participates with influence in or leads departmental and cross-functional taskforces and initiatives.Ability to travel up to 10% of the time domestically and internationally.Estimated compensation: $180-200K/year
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