Associate Director, Regulatory Submission Project Management

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.

When & where:

• Work Location: Tarrytown, NY or Warren, NJ

• Hybrid; 4 days per week on site

Discover your role:

• 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

This role requires:

• 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.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)