Director/Sr Director, Regulatory Affairs Strategy - Tarrytown , New Yo
6 days left
- Job Board
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. Develop regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management and by analysis of guidances and assessment of drug developed for similar indication to obtain approval of activities in support of Regenerons 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. This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development of all aspects of Regenerons 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., * Ph.D. or Pharm D. with 8-12 years experience * Experience as liaison with FDA and other health authorities for assigned programs * Experience in leading regulatory activities associated with assigned drug development programs. * Experience in management of the planning, preparation and submission of licensing applications (BLA/MAA). * Experience in monitoring 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. * Management/ Mentorship experience., 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.