This position involves applying a proven understanding of CMC elements and regulatory requirements to support, and provide guidance to Oncology/ Hematology teams in Japan. This position also supports all CMC regulatory filing activities including the preparation of the Japanese NDA, PCA, and MCN applications and dossiers as well as RTQs from PMDA for CMC parts with Global Regulatory CMC and CMC Regulatory Science.

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

• Develops and maintains a solid understanding of regulatory requirements and the available regulatory guidance documents and resources.
• Assists with the planning, scientific writing and critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, amendments, and supplements (eCTD) to ensure conformance with regulatory requirements and to provide a high-quality regulatory submission.
• Must have excellent communication skills, both written and oral.
• Must be able to lead through ambiguity and make decisions based on regulatory requirements while working independently and with various cross-functional teams.
• Acts as product liaison and corresponds with PMDA for CMC related submissions and information requests.
• Assesses CMC changes against regulatory filings to ensure compliance.
• Assesses manufacturing processes/specifications against regulatory filings for clinical product release requests.
• Maintains awareness of project timelines in order to ensure on-time submissions.
• Participates as needed in agency meetings to effectively communicate Regeneron positions and understand agency feedback to support submissions.

This role might be for you if:

• Possess a Strong biopharmaceutical or regulatory background.
• Attention to detail.
• Ability to interpret, communicate, strategize.
• A strong work ethic is a must.
• Ability to collaborate with different teams and to apply experience and “lessons learned” is important.

We seek over 10 years' proven experience for regulatory CMC of pharmaceuticals and biologics for completing PMDA CMC consultations, NDA, PCA and MCN submissions in Japan. Biologics-specific regulatory knowledge & experience is critical, whilst Gene therapy knowledge would be 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.