2. For the development product, prepares and directs the regulatory documentation to support clinical trial applications, INDs, and amendments, as required, in accordance with regulations, guidance and legal obligations in the US. Experience with Canada, EU, UK, and Greater China a plus.
3. Interaction with the Regulatory, Clinical Operations and other functions to ensure optimal execution of the agreed regulatory strategy for development of medicinal products.
4. Manages interactions with regulatory consultants and contract research organizations as needed.
5. Represents the Regulatory Affairs function at cross-functional submission and study management team meetings.
6. Participate in technical review of clinical protocols and technical review of data.
7. Responsible for maintaining strong knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to project teams.
8. Work with technical and medical writing to direct and submit product prioritization designation requests (e.g., orphan drug, breakthrough therapy, fast track, accelerated approval, PRIME, etc.) in countries of interest.
9. Works with appropriate internal team members to direct and submit initial PIP applications and modifications, as needed.
10. Work with medical writing and Clinical Operations to support and ensure timely safety reporting to regulatory agencies.
11. Work with technical and medical writing to direct document preparation timelines and communicate with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables.
12. Work collaboratively with head of CMC to direct preparation of CMC documentation, as needed, per regulatory requirements
13. Maintain archive and track of ongoing submissions.
14. Work directly with the electronic publisher to get submissions published.
Requirements:1. Bachelor’s Degree required; advanced degree preferred