The Senior Manager, Regulator Affairs applies/integrates knowledge of global regulations governing pharmaceutical drug development to all aspects of Regeneron's quality, preclinical, and clinical drug development programs as well as policies and procedures. This is so that our Development teams are able to meet all objectives within specified timelines and the vital state of compliance is maintained relative to all regulatory commitments/requirements.
In this role, a typical day might include the following:
Act as liaison between company and health authorities (FDA, EMEA, etc.) for assigned programs. Lead all regulatory activities and develop regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management. Our goal is to acquire approval of activities for Regeneron's development and marketing objectives, by analysis and assessment of drug developed for similar indication.Contribute in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.Provide mentorship 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 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. Responsible for the planning, preparation and submission of regulatory documentation.Provide 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.
This role may be for you if you have:
An advanced degree in a science field is required. Masters Degree minimum.7 years prior regulatory experience in the pharmaceutical industry.Research laboratory, process development or manufacturing experience with biotechnology products is highly desirable.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.