Associate Director, Regulatory Affairs - Labeling: Job ID - 1297CA
Ascendis Pharma
Palo Alto, california
The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required.
The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to meet agreed timelines and works both independently and in a team environment. Global coordination is also required and work with external partners may be required.
Key responsibilities:
· Drive process for development and management of US & Americas labelling content for initial and updated labels, including...