Associate Manager - Contract - New York City
If you thrive on driving regulatory milestones, leading cross-functional teams, and turning strategy into successful submissions, this could be your next challenge.
Proclinical is seeking an Associate Manager, Reg. Project Management, to join a dynamic team in the pharmaceutical industry. This position offers the opportunity to make a meaningful impact on regulatory programs within the haematology space. The role requires 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.
The Associate Manager's responsibilities will be:
- 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 having difficulty in applying or if you have any questions, please contact Alex Bill at a.bill@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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