Website KBP Biosciences
KBP is a world-class biotechnology research & development organization dedicated to providing innovative therapies for unmet medical needs. Our integrated discovery and development platform enables us to efficiently bring new drugs from bench to clinics around the world.
Director of Regulatory Affairs
(Director/Senior Director level, 1.0 FTE)
JOB TYPE: Full-time
The Director of Regulatory Affair will provide leadership in the evaluation, development, implementation, and management of regulatory strategy. The individual in this role will be part of R&D and other important areas. This position requires a critical and strategic thinker who has previous experience and will offer opportunities to help drive key decision-making activities within the Company.
QUALIFICATIONS AND BACKGROUND REQUIREMENTS
Educational Requirements: MS or PhD
Professional Work Experience
- A minimum of 10 years of relevant experience in US regulatory affairs/drug development
- Experience in the coordination and preparation of document packages for regulatory submissions to ensure alignment and compliance with local and regional registration requirements as well as with company objectives
- Keeps abreast of US regulatory procedures and changes
- Assists with planning interactions with regulatory agencies in the US, EU, Asia
- Extensive regulatory agency interactions and filing experience
- Extensive expertise with regulatory-related development procedures (e.g., scientific advice, orphan designation, pediatric development plans, fast track, breakthrough).
- Global experience and/or knowledge of ICH regulations
- The ability to work independently is very important.
- Excellent communication skills
- Intercultural sensitivity