Director, Regulatory Affairs - United States
- Defines appropriate regulatory strategies to support successful global clinical development plans with focus in the US, EU, and Japan.
- Provides regulatory support to inter-departmental project teams.
- Evaluates and defines regulatory requirements needed for clinical trial applications and marketing approval applications in targeted regions.
- Advises company scientists of any unique scientific/regulatory issues that will have an impact on drug development.
- Works with global regulatory team member to agree contents for timely submissions to Health Authorities.
- Responsible for coordinating the preparation and regulatory review of documents for regulatory submissions from all areas of the company.
- Ensures that data provided are presented clearly and succinctly to optimize the regulatory review and approval process.
- Directs the activities of and interacts with other company departments in the preparation of initial INDs, CTAs, VHPs and regulatory dossiers for marketing applications.
- Works with Regulatory Operations group to ensure preparation of dossiers containing preclinical, clinical, and technical data in the required eCTD format for submission to obtain regulatory approvals.
- Liaise with FDA and other health authorities as needed (e.g. submissions, telephone contacts, teleconferences, meetings).
- Coordinates the preparation of responses to questions and inquiries from Health Authorities.
- Prepares and submits IND amendments, safety reports, DSUR and NDA annual reports in accordance with regulatory submission schedules and regulations.
- Ensures accurate retention in the archival system of all regulatory submissions and contacts with health authorities.
- Keeps company employees informed of relevant regulatory guidance documents, regulations and information.
- Minimum Bachelor?s degree in scientific discipline, advanced scientific degree preferred.
- A minimum of 5 years direct responsibility for regulatory affairs with at least 8 or more years of drug development experience.
- Oncology experience is highly preferred.
- Strong knowledge of regulations/guidelines governing development of pharmaceuticals; experience working with international regulatory agencies.