Sr Regulatory Submission Project Management Specialist

Responsible for project management of submission deliverables 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).

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

Responsible for project management of submission deliverables 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).

Schedules and manages routine regulatory submissions, such as those for IND safety reports, clinical site documentation updates (1572s), lot releases, promotional pieces and protocol amendments

Manages 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)

Creates and manages submission plans (Table of Contents), timelines and responsibility matrices through cross-functional discussions, and tracks submission deliverables to maintain the target filing date

Manages overall completeness of scheduled submissions and coordinates with Regulatory Operations on submission timing, and document status

Coordinates submission documents through review cycles and provides guidance to cross-functional groups on uploading submission documents to the regulatory submission document management system

Conducts cross-functional kickoff meetings for routine reoccurring submissions such as those for BLA annual reports, consensus meetings on critical submission documents, and IBs

Facilitates or conducts kickoff meetings for major submissions, including those for INDs, CTAs, BLAs, sBLAs and MAAs and variations

Provides contributions to other submission activities, such as Development Safety Update Reports (DSUR) and provides guidance on cross-reporting obligations, which include reporting of IND safety reports to multiple INDs

Drafts cover letters for routine submissions, including those for clinical site documentation, lot releases and protocol amendments

Updates portfolio and management review timelines to help prepare for cross-functional and upper-management discussions

Provides and retrieves requested submission documents to and from partners and CROs

Assists with regulatory inspection activities

Identifies and communicates regulatory system enhancement needs or technical issues to management, as needed

This role might be for you if:

Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).

Requires eCTD knowledge.

Project management skills desired.

Working knowledge with MS Office applications and Adobe Acrobat is required. Working knowledge of MS Project and electronic document management systems (eg, SharePoint) is 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.