Associate Director, Regulatory Submission Project Management

About the role

Join our Regulatory Affairs team as an Associate Director to lead strategic planning and execution of regulatory milestones from IND Project Approval (IPA) through post-marketing. You will serve as the Reg PM lead for assigned therapeutic area(s) and drive organizational excellence and consistency across regulatory programs.

Responsibilities

• Demonstrates independent and strategic thinking, serving as a subject matter expert and providing 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.
• Strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
• 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.

Qualifications

• Strong communication and interpersonal skills.
• Ability to manage multiple projects simultaneously.
• Experience in leading cross-functional teams.
• Proven ability to manage regulatory submissions and ensure compliance.
• Excellent problem-solving and decision-making skills.

Skills

• Regulatory Affairs expertise.
• Project Management skills.
• MS Project proficiency.
• Knowledge of Regulatory Agency guidelines.
• Effective communication and collaboration skills.

Benefits

At Regeneron, we offer a competitive and comprehensive total rewards package which may include, depending on country and role:

• 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.

Pay

$157,200.00 - $256,600.00 annually

Schedule

Hybrid; 4 days per week on site