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Associate Director/Director, Regulatory Affairs

Company Name:
IBM Company
Job Description:
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 markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Summary:
This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to 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.
Responsibilities:
Develop regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management and by analysis of guidance 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
o Management of all regulatory activities associated with assigned drug development programs
o Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals
o Provide guidance to multidisciplinary teams on the regulatory requirements to support clinical development, include preparation and maintenance of IND or CTA filings. Oversee development of all regulatory filings in support of program
o In collaboration with team, perform/manage critical analyses of data (clinical, preclinical and manufacturing), independently develop interpretations and conclusions. Perform reviews of clinical protocols and of clinical and preclinical study reports with respect to alignment with program strategy and consistency of scientific interpretations/messages, clarity, completeness, and regulatory requirements
o Lead multidisciplinary teams in the authoring of regulatory communications such as regulatory briefing packages
o Accountable for ensuring the completeness and accuracy of information provided in regulatory submissions
o Supervises regulatory staff with the planning, preparation and submission of all regulatory documentation
Plans and then executes the preparation and submission of licensing applications
o Provide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of a Biologics Licensing Application (BLA) and MAA.
o Assist with the scientific writing and provides critical review of application. Evaluate for clarity, and completeness; for consistency of scientific key messages and between proposed labeling and scientific dossier; and for conformance with the regulatory requirements,
o Manage timelines/budgets with project management as appropriate and provide progress updates to senior management
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.
Experience and Required Skills:
Qualified candidates should have an advanced degree in a science related discipline and a minimum of 10 years of pharmaceutical industry experience, at least 5 of which should include regulatory experience. Research laboratory, process development or manufacturing experience with biotechnology products is 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 Regenerons unwavering commitment to combining good science & good business.
Apply Online:
http://careers.regeneron.com/united-states/clinical-data-management/jobid5138562-associate-director_director-regulatory-affairs-jobs
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