We will use your ability to integrate/apply knowledge of global & Japanese regulations governing drug development to progressing Regeneron's portfolio. This includes preclinical and clinical drug development programs, policies, and procedures. This is an exciting opportunity to demonstrate your knowledge in leading regulatory processes for oncology/hematology products in Japan, thus building Regeneron’s profile with key collaborators locally.

In this role, a typical day might include the following:

We expect you to act as liaison between company and PMDA and other health authorities for assigned programs.

Develop regulatory strategies in collaboration with Regeneron's Regulatory senior management. This includes analysis of guidance and assessment of drugs developed for Oncology/ Hematology. The result is to acquire approval of activities in support of Regeneron’s development and marketing objectives.

Management regulatory activities associated with Regeneron development programs. Participate 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 Japan submissions. Plan and implement Japan regulatory strategies including PMDA consultations for assigned projects in the oncology/hematology portfolio with global regulatory teams.

Complete the timely submissions of marketing applications and post -approval changes for assigned projects.

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.

Supervisory responsibility for the planning, preparation and submission of regulatory documentation.

Provide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of regulatory submissions (biologics)Assist with the scientific writing and review of a BLA and evaluate conformance with the regulatory requirements.Continually monitor newly published PMDA 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 might be for you if:

We require an advanced degree in a science related field.

7 years prior regulatory experience as a regulatory professional having led interactions with Health Authorities, major submissions, and approvals in Japan.

Research laboratory, process development or manufacturing experience with biotechnology products highly desirable.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.