Director, Regulatory Affairs - Immunology & Inflammation
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases . Summary . The Director of Regulatory Affairs- Immunology & Inflammation will provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for Regeneron's clinical asset candidates . Job Duties . This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development of all aspects of Regeneron's quality, preclinical and clinical drug development programs, policies and procedures, so that Development teams are able to meet all objectives within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements . Develop regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management and by analysis of guidance's and assessment of drug developed for similar indication to obtain approval of activities in support of Regeneron's development and marketing objectives within specified timelines. Liaison responsible for communication with FDA and other health authorities for assigned programs. Manage/lead regulatory activities associated with Regeneron assigned drug development programs . Management of the planning, preparation and submission of licensing applications BLA/MAA . Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required . Manage and mentor direct reports and/or junior staff members . Requirements . 10-12 years of industry experience required. Education . MD, Ph. D. r Pharm D. Required . This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business . To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid . Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.