- Oversees as well as executes all regulatory activities of multiple projects including one highly complex project in development and/or supports regulatory activities for assigned marketed product(s) of responsibility.
- Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
- May serve as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility
- Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility.
- May be primary FDA contact for projects of responsibility.
- Responsible for achieving submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA) under oversight of manager.
- Accountable for ensuring all other regulatory submissions within the non-US Americas territories are submitted on schedule by local Takeda affiliates or development partners (eg, PRA or co-development partners) within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
- May develop/author or assist Global Regulatory Lead with development of global regulatory strategy.
- For the project(s) of responsibility, collaborates with EU and/or other regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside the US to ensure regional execution of the strategy as agreed within the global regulatory strategy
- Executes day-to-day activities for projects or delegates to staff with oversight.
- Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
- Assists and attends FDA and other agency meetings.
- Identifies and notifies management of any resource gaps for project responsibility.
- Provides oversight to ensure regulatory compliance of marketed products.
- Present to senior management as requested.