Seeking a Hands-On Director of Regulatory Affairs. Apply today!
My client is a biopharmaceutical company that is focused on developing breakthrough treatments for human disease. Lexicon has advanced multiple drug candidates into clinical development. They are presently devoting most of their resources to the development of their two most advanced drug candidates. LX4211 is an orally-delivered small molecule drug candidate developed as a treatment for type 1 and type 2 diabetes. They have completed two Phase 2 clinical trials of LX4211 in type 2 diabetes. Additionally, Lexicon is also developing telotristat etiprate (LX1032), an orally-delivered small molecule drug candidate as a treatment for characinoid syndrome. They are presently conducting a pivotal Phase 3 clinical trial of telotristat etiprate in patients.
Director of Regulatory Affairs The Woodlands, Texas and Princeton, New Jersey
As our clientís Director of Regulatory Affairs, you will oversee the development of regulatory operations strategies and implementation of technical systems for regulatory operations aspects of pre-market and post-market products, filing of applications and interactions with health authorities pertaining to regulatory operations issues or inquires. The position is responsible for oversight and maintenance of existing IND/CTA submissions on assigned programs. This involves the preparation of all amendments and annual reports in compliance with FDA regulations. Additionally, the selected individual will be responsible for assisting with pre-IND meeting briefing packages and initial IND submissions for new programs; representing the department on multi-disciplinary development teams and supervising staff.
To qualify, you should hold a Bachelorís degree in Science, Chemistry or Biology and possess 8 or more yearsí of focused experience in regulatory affairs working in the pharmaceutical/biotech industry. Extensive experience with regulatory strategy, IND and NDA submission experience, along with global regulatory experience are essential. Your background should also include extensive knowledge of global regulatory requirements with a strong focus on US, EU and ICH requirements, face to face meetings with the FDA, proven experience with Electronic Document Management systems, and the management and development of staff. Working with my client, you will earn a competitive salary, and a generous benefits package including medical, dental, vision, AD&D and life insurance, retirement plan, educational assistance programs, paid time off, plus the ability to be part of team who is changing the landscape of medicine and making a difference in patientís lives. Please send your resume, for immediate consideration. Our Client is an Equal Opportunity Employer.
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