Manager, Regulatory Submission Project Management

SUMMARY:The Manager, Regulatory Submission Project Management will be responsible for leading strategic planning and execution of regulatory milestones from IND Project Approval (IPA) to postmarketing. The incumbent will report to the Sr Mgr Regulatory Submission Project Management and serve as the Reg PM lead for assigned therapeutic area (TA) and ensures success for regulatory programs under that TA.JOB RESPONSIBILITIES:

Provides oversight of therapeutic area(s) by guiding other team members who are responsible for project managing regulatory milestones such as pre-IND or Scientific Advice, INDs and CTAs, BLAs, sBLAs, MAAs and Type II variations, and BLA annual reports

Partners with Regulatory Affairs in driving program team to successfully meet regulatory milestones

Facilitates Global Regulatory Sub-team meetings with Regulatory Affairs liaison as the meeting chair

Conducts working group meetings to monitor and track progress of major submissions

Conducts kickoff meetings for major submissions, including those for INDs, CTAs, BLAs, sBLAs and MAAs and variations

Reviews regulatory portfolio slides for complete and accurate milestones dates to help prepare for cross-functional and upper-management discussions

Creates submission timelines and responsibility matrices through cross-functional discussions

Maintains accurate program timelines for cross-reporting with other functional groups

Communicates program projections and progress and serves as the key contact for coordinating regulatory activities and milestones

Provides guidance to 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

JOB REQUIREMENTS:

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

Requires eCTD knowledge.

Microsoft Project skills required.

Project management skills desired.

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

Education

Bachelor’s Degree

Experience

6+ years of industry and/or relevant experience

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.Salary Range (annually)$110,900.00 - $181,100.00