Manager, Regulatory Submission Project Management

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). May lead other team members in Regulatory Submission Project Management, and provide support and backup to management as needed.

In this role a typical day may include the following:

• You have solid understanding of submission documents required by applicable Regulatory Agencies (eg, FDA, EMA, ICH, etc).
• 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 mentorship 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
• Provides input and proposals on 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 run in the system.
• Leads activities related to programs that involve partnerships that may involve additional complexities due to documents being exchanged across companies.
• Provides oversight on 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)
• Builds and manages submission plans (Table of Contents), timelines and responsibility matrices through cross-functional discussions, and tracks submission deliverables through the filing date
• Leads overall completeness of scheduled submissions and coordinates with Regulatory Operations on submission timing, and document status
• Coordinates submission documents through review cycles 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. 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 mentorship 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, and may prepare slides for these presentations
• Provides and retrieves requested submission documents to and from partners and CROs
• Assists with regulatory inspection activities
• Identifies and communicates regulatory system improvement needs or technical issues to management
• Provides proposed solutions to areas requiring system improvements, new or revised processes, or further training or clarifying communications

This role might be for you if:

• Bachelor's Degree required
• 10-12 years of significant experience
• Requires solid understanding of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
• Requires eCTD knowledge.
• Project management skills desired.
• Solid understanding with MS Office applications and Adobe Acrobat is required. Proven understanding 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.