- Lead ex-US regulatory strategy and operational execution for clinical studies.
- Manage IND/CTA submissions for regions including South America, APAC, and EU.
- Interpret regulatory authorities’ feedback, policies, and guidelines.
- Develop study-level regulatory strategic plans.
- Prepare major clinical submissions for regulatory approval.
- Work with program teams to resolve complex project issues.
- Ensure quality and timeliness of IND/CTA submissions.
- Oversee CROs in the management of ex-US CTAs/INDs.
- Collaborate with internal functions to prepare and review submission documents.
Project Management