Sr. Manager Regulatory Submission Project Management
The Sr. Manager will be responsible for project management tasks pertaining to submission documents 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 are looking for the Sr. Manager to lead other team members in Regulatory Submission Project Management, and provide support to management as needed.
In this role, a typical day might include the following:
Provides oversight of therapeutic area(s) by guiding the team who are responsible for INDs, CTAs, BLAs, sBLAs and MAAs and variations in that therapeutic area
Mentor colleagues and cross-functional groups to resolve issues related to timelines, submission documents or other regulatory-related matters that could impact the timeliness or quality of submissions
Help improve the standardizing submission management work, including processes and activities pertaining to the document management system, functionality of systems and how specific document types are handled in the system.
Responsible for having oversight on routine regulatory submissions, such as those for IND safety reports, clinical site documentation updates (1572s), lot releases, promotional pieces and amendments
Handles 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 run submission plans (Table of Contents), timelines and responsibility matrices through cross-functional discussions, and supervises submission deliverables to maintain the target filing date. Identifies potential issues that can delay the process and creates solutions to address issues
Facilitates 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 systems
Establish kickoff meetings for major submissions
Draft cover letters for submissions (protocol amendments, etc)
This role might be for you if you have:
You have 7+ years proven experience and a bachelor’s degree.
You have an understanding of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
You have project management skills.
You have previous experience with MS Office applications and Adobe Acrobat.
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.