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 drug development programs, policies, and procedures, so that the necessary state of compliance is maintained relative to all regulatory commitments.
- Develop regulatory strategies for assigned programs in collaboration with manager
- Management of all regulatory activities associated with assigned development programs.
- Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.
- Provide guidance to multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application or CTA for ex-US studies. Edit or manage the editing of scientific sections of an IND application against the regulatory requirements. Assist with the writing, review and preparation of an IND application. Manage the organization, preparation and review of IND amendments, annual reports and other regulatory documents and correspondence.
- Perform/manage critical analyses of data (clinical, preclinical and manufacturing), independently develop interpretations and conclusions.
- Perform reviews of clinical protocols and study reports to focus attention on deficient/missing items/explanations.
- Accountable for ensuring the completeness and accuracy of all regulatory submissions.
- Works with Regulatory Operations to ensure appropriate planning, preparation and submission of regulatory documentation.
- Management of the planning, preparation and submission process for licensing applications.
- Provide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of a Biologics Licensing Application (BLA) or MAA.
- Assist with the scientific writing and review of a BLA and evaluate conformance with the regulatory requirements.
- 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.
- Develop regulatory strategies for assigned programs by analysis of guidances and assessment of drug developed for similar indication
- Requires an advanced degree such as Pharm.D, PhD, or MS in a science related discipline
- Minimum 3 years prior regulatory experience in the pharmaceutical industry
- Research laboratory, process development or manufacturing experience with biotechnology products highly desirable.
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