Associate Director, Regulatory Submission Project Management

Role Overview

• 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

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

Tech Stack

• PMP

Benefits

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits