Associate Manager, Regulatory Project Management

6-month W2 contract role based in New York City, requiring on-site presence 3-4 days per week.

About the role

If you thrive on driving regulatory milestones, leading cross-functional teams, and turning strategy into successful submissions, this could be your next challenge. This position offers the opportunity to make a meaningful impact on regulatory programs within the haematology space.

Responsibilities

• Collaborate with Regulatory Affairs to drive program teams toward achieving regulatory milestones.
• Facilitate Global Regulatory Sub-team meetings, serving as the meeting chair alongside the Regulatory Affairs liaison.
• Organize and lead working group meetings to monitor and track progress on major submissions.
• Conduct kickoff meetings for significant submissions, including INDs, CTAs, BLAs, sBLAs, MAAs, and variations.
• Review regulatory portfolio slides to ensure accurate milestone dates for cross-functional and upper-management discussions.
• Develop submission timelines and responsibility matrices through cross-functional collaboration.
• Maintain accurate program timelines for alignment with other functional groups.
• Communicate program projections and progress, acting as the primary contact for coordinating regulatory activities and milestones.
• Provide guidance to team members and cross-functional groups to address issues related to timelines, submission documents, or other regulatory matters.
• Oversee therapeutic areas by guiding team members managing regulatory milestones such as pre-INDs, Scientific Advice, INDs, CTAs, BLAs, sBLAs, MAAs, and variations.

Requirements

• Bachelor's degree in a relevant field.
• Strong knowledge of applicable regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, ICH).
• Proficiency in eCTD (electronic Common Technical Document) processes.
• Skilled in Microsoft Project and other MS Office applications.
• Familiarity with Adobe Acrobat and electronic document management systems (e.g., SharePoint) is desirable.
• Strong project management skills and the ability to lead cross-functional teams effectively.