Associate Director, Regulatory Submission Project Management

Regeneron Pharmaceuticals•Tarrytown, GA

2d•$157,200 - $256,600•Hybrid

About The Position

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our Regulatory Affairs team. This individual will be responsible for providing senior leadership in the strategic planning and execution of regulatory milestones from IND Project Approval (IPA) through post marketing. They will serve as the Reg PM lead for assigned therapeutic area(s) (TA) and drives organizational excellence and consistency across regulatory programs within the function.

Requirements

Minimum Bachelor’s Degree with 10+ years of combined industry and relevant experience
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 required; PMP certification or equivalent preferred.
Working knowledge with MS Office applications and Adobe Acrobat is required.

Nice To Haves

Working knowledge of electronic document management systems (eg, SharePoint) is desirable.

Responsibilities

Demonstrates independent and strategic thinking, serves as a subject matter expert, and provides leadership and direction to the Reg PM team.
Acts as a key decision-maker and escalation point, partnering closely with senior management to shape and advance the regulatory project management function.
Provides strategic oversight and leadership across therapeutic area(s), directing team members 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; accountable for functional quality and consistency across the portfolio
Partners with senior Regulatory Affairs leadership to drive program teams to successfully meet regulatory milestones, influencing strategy and prioritization across assigned therapeutic areas
Leads and facilitates Global Regulatory Sub-team meetings with Regulatory Affairs liaison as the meeting chair; drives alignment and resolution of complex cross-functional issues
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 and owns regulatory portfolio slides for complete and accurate milestone dates; presents to cross-functional and senior/executive management stakeholders and drives informed decision-making
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
Serves as the senior escalation point and strategic advisor for team members and cross-functional groups, resolving complex issues related to timelines, submission documents, or regulatory matters impacting the timeliness or quality of submissions; establishes best practices and process improvements to enhance functional effectiveness