Sr Mgr Regulatory Affairs
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.
In this role, a typical day might include the following:
* Act as liaison between company and FDA and other health authorities for assigned programs
* Develop regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management and by analysis of guidance’s 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
* Management of all regulatory activities associated with Regeneron development programs.
o Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.
o Provide guidance to multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application or CTA for ex-US/ex-EU 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. o 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. o Accountable for ensuring the completeness and accuracy of all regulatory submissions. o Supervisory responsibility for the planning, preparation and submission of regulatory documentation.
* Management of the planning, preparation and submission process for licensing applications.
o Provide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of a Biologics Licensing Application (BLA).
o 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 guidance’s and assessment of drug developed for similar indication
This role might be for you if:
* Requires an advanced degree MD, Ph.D, PharmD
* Research laboratory, process development or manufacturing experience with biotechnology products highly desirable.
* 7 years prior regulatory experience in the pharmaceutical industry
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.a, pain, cancer and infectious diseases.