Director, US Regulatory Affairs at Pharmaceutical Company in Remote, United States —
- Pharmaceutical Company
- Remote, United States USA
- 7/12/20 2020-07-12
Job ID: 69689
The Director of Regulatory Affairs will: work with multi-functional teams to develop the US regulatory strategy and contribute to the development of the Global Clinical Development Plan; effectively liaise, negotiate and partner with the US Health Authorities (FDA, CDRH, etc); direct, coordinate and implement the preparation of US regulatory submissions and provide regulatory support across all global projects; meet aggressive deadlines to ensure that the US Health Authorities receive timely and quality submissions, leading to fast and successful approval of INDs and NDA in the US.
- Develop US regulatory strategies to support successful biomarker-driven global clinical development plans and NDA plans.
- Evaluates and defines regulatory requirements needed for clinical trial applications and NDA applications in the US.
- Responsible for coordinating the preparation and regulatory review of documents for regulatory submissions.
- Ensures that data provided are presented clearly and succinctly to optimize the regulatory review and approval process.
- Responsible for interfacing with the US Health Authorities (FDA, CDRH), facilitating approval of regulatory submissions, and coordinating appropriate responses to US Health Authorities with appropriate personnel and departments to resolve new or outstanding regulatory issues. Prepares and submits IND/SUSAR/Annual report/IND amendments/NDA, and etc, regulatory activities in accordance with regulatory submission schedules and regulations.
- Leads the planning, preparation, and execution of face to face meetings or teleconferences with US Health Authorities.
- Work with consultants and vendors to ensures accurate retention in the archival system of all regulatory submissions and contacts with health authorities.
- Provides training and mentorship to the company staff. Independently maintains US Regulatory Intelligence and US regulatory guidelines.
- Advises and identify any unique scientific/regulatory issues that will have an impact on drug development.
- Minimum Bachelor’s degree in a scientific discipline, advanced scientific degree preferred.
- A minimum of 5 years of direct responsibility for regulatory affairs with at least 8 or more years of drug development experience.
- Oncology experience is highly preferred.
- Experience in Companion Diagnostic development is a plus.
- Strong knowledge of regulations/guidelines governing the development of pharmaceuticals; experience working with international regulatory agencies.
- Willingness to work a flexible schedule/hours.