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Sr. Director, Regulatory Affairs
If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA (R) (aflibercept) Injection, ZALTRAP (R) (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST (R) (rilonacept) Injection for Subcutaneous Use. Regeneron has filed a regulatory application with the U.S. Food and Drug Administration (FDA) for a second indication for EYLEA. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.
The Senior Director, Regulatory Affairs is responsible for integrating and applying knowledge of global regulations governing pharmaceutical drug development to all aspects of Regeneron's preclinical and clinical drug development programs, policies, and procedures, to ensure the rapid and successful development and registration of Regeneron products while maintaining compliance with all regulatory requirements and commitments..
Essential Duties and Responsibilities include, but are not limited to the following:
' Leads multidisciplinary teams on the content, format, style and architecture of marketing applications (BLAs and MAAs) and the strategies for gaining regulatory approval.
' Writes and/or reviews eCTD sections and evaluates relative to stratgegy and for
conformance with the regulatory requirements.
' Contributes to multidisciplinary teams on the regulatory strategy for drug development including CMC, preclinical, and clinical requirements at different stages of development.
' Familiar with US and EU guidances/guidelines applicable to same.
' Contributes to multidisciplinary teams on the regulatory requirements for publically shown materials, including prmotional materials.
' Leads multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application, Clinical Trials Application (CTA) and the IMPD.
' Liaison with competent regulatory authorities on routine matters and serve as the Regeneron lead for regulatory meetings with Agencies.
' Supervises the preparation of IND (or CTA) amendments, annual reports and other routine regulatory submissions.
' Writes and/or reviews more strategic regulatory submissions such as briefing packages for FDA meetings or EU scientific advice proecdures.
' Reviews critical analyses of data (clinical, preclinical and manufacturing) and independently develops interpretations and conclusions.
' Performs meaningful reviews of clinical/preclinical/manufacturing protocols and studies reports.
' Manages the performance and development of staff. Leads training on applicable requirements for scientific staff as required.
' A MD or PhD in Life Science or a related field and a minimum of 10 plus years in biotechnology/pharmaceutical industry of which a minimum of 7 years was in regulatory affairs.
' Prior experience with biotechnology products a plus.
' Works independently with all levels of mgmt internally and externally under the minimal supervision of the department head.
' Team leadership experience, participates in hiring, termination, performance review and disciplinary processes.
' Previous regulatory leadership experience with a global Phase 2/3 development program, including familiarity with CHMP processes/procedures. Direct experience with analgesic drug development highly desirable.
' Expert knowledge of 21 CFR Parts 50, 54, 56, 58, 210, 211, 312, 314, 600, 601, and stays current on newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs.
' Excellent communications, management and advanced negotiation are a must
We offer a competitive compensation and benefits package including stock incentives, 401k with company match, as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.
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