Sr. Manager Regulatory Submission Project Management
Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: May 14, 2022
Job Description:
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.
Keywords: Regeneron Pharmaceuticals, Inc., Newark , Sr. Manager Regulatory Submission Project Management, Executive , Basking Ridge, New Jersey
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