Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
The Associate Director/ Director, Regulatory Affairs, will work with multi-functional teams to develop the regulatory strategy and ensure that regulatory requirements for assigned products are complete. The position will liaise and lead team meetings with FDA and other Health Authorities.
Essential Functions of the Job (Key responsibilities)
- 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 Incyte 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 Incyte 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 employees informed of relevant regulatory guidance documents, regulations and information.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- 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.