Temporary - Associate Manager, Regulatory Project Management

• Bachelor’s Degree

• 5+ years of industry and/or 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 desired.

• Working knowledge with MS Office applications and Adobe Acrobat is required. Working knowledge of electronic document management systems (eg, SharePoint) is desirable.

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.

• Partners with Regulatory Affairs in driving program team to successfully meet regulatory milestones

• Facilitates Global Regulatory Sub-team meetings with Regulatory Affairs liaison as the meeting chair

• 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 regulatory portfolio slides for complete and accurate milestones dates to help prepare for cross-functional and upper-management discussions

• 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

• Provides guidance to 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

• May provide oversight of therapeutic area(s) by guiding other team members who are 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