The Regulatory Affairs (RA) Associate Director, Labelling will be responsible for labelling 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, Labelling 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 amp; Americas labelling 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, and collaborate with other market leads to develop local labeling in line with global strategies and local regulations
· Coordinate US labelling activities for regulatory submissions, product maintenance and safety variations, including developing timelines, involving relevant SMEs, and handling reviews
· Understand and interpret regulatory requirements for labelling 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 labelling content
· Ensure and maintain tracking and archiving of approved labels
· Develop project timelines and manage labeling projects from initiation to completion
· Contribute to development of key labelling processes and infrastructure
· Work closely with global labelling managers to ensure consistency and alignment
Requirements
· BS/BA or equivalent degree in a Scientific Discipline, advanced degree desirable
· Regulatory experience of at least 8 years, and at least 3 years direct experience with labelling in the US
· Solid knowledge of regulatory labelling requirements in the US, have an understanding of current global and regional trends and ability to assess the impact of these requirements
· 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 product strategy teams, product review teams, HA response teams, labeling stakeholders, junior team members, or others as needed
· Strong understanding of the purpose of the Target Product Label and CCDS and the associated implications on labeling globally, downstream processes, and compliance needs
· Participates with influence in or leads departmental and cross-functional taskforces and initiatives
· Interpret labeling regulations and guidance
· Responds to challenging situations in a calm and confident manner
· Embraces change and quickly alters course in response to new challenges
· Ability to travel up to 10% of the time domestically and internationally
Estimated compensation: 180-200K/year
Benefits