Senior Director/ Executive Director Regulatory Affairs
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 . This management position in Regulatory Affairs involves the ability to lead and manage the regulatory affairs organization so that all corporate objectives are met within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements. In addition the position assists corporate senior management in understanding Regulatory strategies/processes while developing corporate objectives and, importantly, understanding the impact of decisions across therapeutic areas . Job Duties . Responsible for regulatory strategies for all development programs to ensure Regulatory Agency approval s within specified timelines of all activities in support of Regeneron's corporate development and marketing objectives . Manages liaisons and/or provides direction to regulatory representatives to project teams who effect and communicate regulatory strategies in consultation with the Executive Director . Review critical regulatory communications. Evaluate conformance with the regulatory requirements, clarity, and completeness . Responsible for ensuring necessary state of compliance for all regulatory commitments/requirements . Supervises/manages others to ensure that all reporting requirements and other commitments are met with respect to INDs, BLAs, CTA, MAAs, etc . Supports department liaisons with their project specific communications, including Agency meetings . Responsible for the completeness and accuracy of information provided in regulatory submissions . Supervises regulatory staff with the planning, preparation and submission of all regulatory documentation . Permanent member of PRC and RCRC . Responsible for the planning, preparation and submission of licensing applications . Manages liaisons and/or provides direction to regulatory representatives to project teams who effect and communicate to multidisciplinary teams the content, format, style architecture and timing of a Biologics Licensing Application BLA and MAA . Review application. Evaluate conformance with the regulatory requirements, clarity, and completeness . Supervise Regulatory staff with respect to commercialization activities associated with new product registrations . Responsible to senior management for timelines/budgets . 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 . Requirements . Education . Requires advanced degree in a science related discipline . Experience . A minimum of 15 years of pharmaceutical industry or related experience, at least 5 of which should include regulatory experience . Research laboratory, process development or manufacturing experience with biotechnology products highly desirable . Must possess excellent written and verbal communication skills . 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.