Associate Manager, Regulatory Submission Project Management - Oncology

The Associate Manager, Regulatory Submission Project Management will be responsible for handling submissions such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). We expect you to serve as the Regulatory Submission lead for multiple programs and ensure success for regulatory programs. We believe this opportunity would be focused on our Oncology portfolio.

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

• Leading submission activities related to pre-IND or Scientific Advice submissions, INDs and CTAs, BLAs, sBLAs, MAAs and Type II variations, BLA annual reports and Investigator Brochures (IBs)
• Working with manager to identify potential issues that could impact the target submission date and working with Regulatory Project Management (Reg PM) and Regulatory Publishing to reach a consensus around a solution.
• Creating and running submission table of contents (TOCs) and tracking submission deliverables to maintain submission date.
• Managing overall completeness of scheduled submissions and coordinating with Regulatory Publishing on submission timing, and document status

This role might be for you if:

• You have a depth of knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications
• You know eCTD
• You have previous global submission experience
• You are able to prioritize work base on firm deadlines and able to adjust to changing priorities

To be considered, we are looking for at least 3 years of submission management experience and at least 4 years of Life Science experience. This is a fully remote role and we forecast the need to travel to the office on a needs basis.  

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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$92,500.00 - $150,900.00