Associate Manager, Regulatory Project Management / Associate Manageress, Regulatory Project Management

Associate Manager - Contract - New York City

If you thrive on driving regulatory milestones, leading cross-functional teams, and transforming strategy into successful submissions, this could be your next challenge. Proclinical is seeking an Associate Manager in Regulatory Project Management to join a dynamic team in the pharmaceutical industry. This position provides an opportunity to make a meaningful impact on regulatory programs within the hematology space, requiring on-site presence for 3-4 days per week.

Primary Responsibilities:

The successful candidate will lead strategic planning and execution of regulatory milestones, from initial project approval to post-marketing activities.

Skills & 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.

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.

If you are interested in this exciting opportunity, please apply online using the form below. Only applications matching the job profile will be considered.

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