Position Overview
The RA Director, Labeling is responsible for ensuring compliance with US regulatory labeling requirements and managing internal labeling activities related to regulatory submissions and product maintenance. This role involves prioritizing tasks to meet deadlines, working both independently and collaboratively, and coordinating globally with external partners as needed.
Key Responsibilities
- Lead the creation and management of labeling content for the US and Americas, including initial and updated labels. Collaborate with the Global Regulatory Lead to develop strategic messaging.
- Provide expertise on Company Core Data Sheet (CCDS), US Prescribing Information (USPI), and Canadian Monograph content. Work with market leads to align local labeling with global strategies and regional regulations.
- Oversee US labeling activities for regulatory submissions, product maintenance, and safety updates. Develop project timelines, involve relevant subject matter experts (SMEs), and manage the review process.
- Interpret and apply regulatory requirements to ensure compliance with applicable labeling regulations.
- Conduct competitive intelligence on global labeling trends and provide strategic recommendations.
- Support and advise on interactions with the FDA and other agencies regarding labeling content.
- Maintain accurate tracking and archiving of approved labels.
- Develop and manage project timelines for labeling projects from start to finish.
- Contribute to the enhancement of labeling processes and infrastructure.
- Work closely with global labeling managers to ensure consistency and alignment across regions.
Requirements
- Bachelor’s degree or equivalent in a scientific field; advanced degree preferred.
- At least 8 years of regulatory experience, including a minimum of 3 years specifically in US labeling.
- Strong knowledge of US regulatory labeling requirements and an understanding of global and regional trends and their impacts.
- Experience working with international teams.
- Excellent collaboration and communication skills.
- Ability to think creatively and develop solutions.
- Proficiency in interacting with commercial, legal, safety, medical, and other cross-functional teams.
- Skilled in document editing and familiar with Microsoft Office (Word, PowerPoint, Excel).
- Experience with document management systems and labeling systems.
- Capable of providing guidance to product strategy teams, review teams, health authority response teams, and other stakeholders.
- Solid understanding of the Target Product Label and CCDS, including global implications, downstream processes, and compliance needs.
- Experience leading or participating in departmental and cross-functional taskforces and initiatives.
- Ability to interpret labeling regulations and guidance effectively.
- Responds confidently and calmly to challenging situations.
- Adaptable to change and capable of adjusting to new challenges.
- Willing to travel up to 10% domestically and internationally.
