Preparing for regulatory submissions and interactions requires seamless communication and continuity across multiple disciplines. While many consulting companies offer regulatory project management as a capability, Premier Consulting Regulatory Project Managers (PMs) elevate the position by acting a single point of contact for sponsors throughout the entire regulatory project life cycle. Often serving as the team lead, the Regulatory PMs define and implement best practices across a range of projects, alleviating potential stressors within and between functional areas.

By coordinating all project logistics, timelines, and communications, the Regulatory PM allows all internal and external stakeholders – including chemistry, manufacturing, and controls (CMC), clinical operations, nonclinical operations, and pharmacokinetics (PK) – to focus on the scientific aspects of a regulatory project, ensuring that deadlines are met and expectations are in sync. Essential to the PM’s success are well-honed abilities to navigate these responsibilities as both sponsor liaison and partner.

Regulatory project management responsibilities

Unlike PMs at other consultancies, whose responsibilities may encompass little more than managing timelines, Premier Consulting has reimagined the Regulatory PM position as a multi-dimensional project facilitator with a wide range of roles and responsibilities. With this comprehensive mandate, the PM can facilitate the buildout of an entire development program, from pre-IND to IND, to Breakthrough and/or Fast Track Designation, culminating in the NDA and commercialization.

Key Roles and Responsibilities of a Regulatory PM

• Serve as primary point of contact
• Set up, organize, and maintain collaborative platforms
• Manage document transfer – internal and external
• Manage meeting communications
  • Scheduling – internal and external
  • Developing and distributing meeting agenda and minutes
• Handle administrative tasks
  • Module 1 documents: administrative and prescribing information
  • FDA forms, including:
    • 1571: for Investigational New Drug (IND) applications
    • 356h: for New or Abbreviated New Drug Applications (NDAs or ANDAs)
    • 3674: certifications to accompany drug, biological product, and device applications/submissions
    • Transfer of Regulatory Obligation (TORO) (i.e., from the sponsor to Premier Consulting)
  • Cover letters
• Manage project finances
  • Manage/track hours
  • Communicate billing schedules

Regulatory project management tools

A further differentiator for our PMs is access to Premier Consulting’s project dashboard, a unique tool that affords the entire team a real-time view of a project’s status, updated on a daily basis. Whereas others may offer dashboards built with off-the-shelf project management software, this proprietary dashboard incorporates an integrated, easy-to-use Smartsheet tailored to each project’s needs.

The dashboard thus illuminates critical items that may impact submission timelines, along with billing schedules, milestones, the status of deliverables (including designation of responsibility), and overall project timelines. Many sponsors routinely use this dashboard to demonstrate progress to executive teams and update them on performance against timelines and other key performance indicators.

Sample Project Dashboard

Regulatory project management processes

Our PMs handle all projects that include IND or NDA submissions as well as many other regulatory projects that benefit from early-stage planning and coordination, such as interactions with the FDA. When a sponsor gains an understanding of the FDA’s expectations through a pre-IND meeting, pre-NDA meeting, Type A meeting, Type C meeting, or End of Phase II meeting, the Regulatory PM facilitates outreach to and integration of the relevant specialists on our multidisciplinary team who can complete those requirements to keep the program on track.

Premier Consulting’s PMs are heavily involved in completing administrative documents such as FDA forms and cover letters and submitting them through the agency’s Electronic Common Technical Document (eCTD) gateway, relieving sponsor team leads of those paperwork responsibilities. The PMs also contact the FDA to obtain pre-assignment numbers for every regulatory submission. Similarly, they oversee all collaborative platforms, ensuring consistency across working spaces so that new members of a project team, whether on the sponsor or the Premier Consulting side, know exactly where to find important documents.

The Regulatory PM also plays an important role in mapping out what is needed after a project closes. For instance, after the submission of an IND, the PM will create an agreement that details the requisite steps for maintaining the IND. Though there are many steps, a key one is the submission of an annual report, which must occur within 60 days of the IND “birth date.”

As the single point of contact, the Regulatory PM’s job is to manage the entire project for the sponsor. In addition to managing the internal team, the PM may manage the sponsor’s team as well as other vendors like CROs or CMOs. Each of our Regulatory PMs has the experience and know-how to organize internal and external teams and to liaise with contractors, depending on the needs of each project.

If you are interested in learning more or in engaging Premier Consulting to manage your regulatory interaction or submission, please contact us.

Author:

Jade Lackey
Senior Manager, Regulatory Project Management