Assoc Mgr Regulatory Submission Project Management

The Associate Manager, Regulatory Submission Project Management will be responsible for leading strategic activities and execution of regulatory deliverables such as INDs, CTAs, BLAs and amendments/supplements, MAAs and variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). We expect the you to serve as the RSPM lead for assigned therapeutic area (TA) and ensure success for regulatory programs under that TA.

• Provide oversight of therapeutic area(s) by guiding colleagues who are responsible for variet of regulatory submissions (IND, CTA, BLA, etc)
• Manage 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)
• Create and manage submission plans (Table of Contents), timelines and responsibility matrices through cross-functional discussions
• 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
• Conducts kickoff meetings for major submissions

You have knowledge of Regulatory regulations (eg, FDA, EMA, ICH, etc).

You bring eCTD knowledge.

You possess project management skills

You work independently and know how to prioritize specific tasks throughout the day.

To be considered, we expect you to have a bachelor’s degree along with 2+ years of experience within the regulatory field. We would also appreciate if you have worked on global projects and covered a number of type of submissions.

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 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. 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.