Senior Manager, Regulatory Submission Project Management

Job Description

The Senior Manager, Regulatory Submission Project Management is 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). Additional responsibilities include collaborating with Regulatory Liaisons, CMC, vendor management and other cross-functional team members, as well as CROs, to help manage ex-US applications by developing and executing standard global document and submission practices. May be required to assist with publishing activities, as needed, and manage other team members in Regulatory Submission Project Management, and provide support to management as needed.
Job Duties

• Provides oversight of therapeutic area(s) by guiding other team members who are responsible for INDs, CTAs, BLAs, sBLAs and MAAs and variations in that therapeutic area
• Provides guidance to other team members 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
• Oversees standardizing submission management work, including processes and activities related to use of the regulatory document management system, functionality of the regulatory document management system and how specific document types are managed in the system. This includes activities related to programs that involve CROs and other partnerships that may involve additional complexities due to documents being exchanged across companies, such as providing specific guidance on the management of global submission documents for EU and other ex-US by collaborating with internal (liaisons, CMC, vendor management) and external (CRO) key stakeholders.
• Provides oversight on routine regulatory submissions, such as those for CTA amendments, 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, including for submissions performed by CROs for ex-US applications; identifies potential issues that could impact the target filing date; and leads discussions to reach a consensus around a solution.
• Coordinates submission documents through review cycles and provides guidance to cross-functional groups on uploading submission documents to the regulatory submission document management system, and may assist in publishing submission documents
• Manages overall completeness of scheduled submissions and coordinates with Regulatory Publishing on submission timing, and document status
• Conducts cross-functional kickoff meetings for routine reoccurring submissions such as those for BLA annual reports, consensus meetings on critical submission documents, and IBs. These meetings can also include regulatory sub-team, ad hoc and therapeutic area discussions that involve Regulatory Liaisons and team members from partner companies
• 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 project timelines to maintain cross-functional and management-level regulatory milestone reporting
• Liaise with Regulatory Publishing, regulatory management and other functional groups to help identify or provide input on potential resource issues
• 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, and provides proposed solutions to areas requiring system enhancements, new or revised processes, or further training or clarifying communications
• Represents Regulatory Submission Project Management on enterprise system or process discussions, including those related to program management and clinical dashboards

Job Requirements

• Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
• Requires eCTD and Non-eCTD Electronic Standard (NeES) 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
• Minimum Years of Experience: 12-14 years
• Bachelors Degree
  

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.