Driving MAA success
Why every submission team needs a regulatory project manager
Within the biotechnology and pharmaceutical industries, it's easy to become laser-focused on day-to-day tasks that may feel far removed from patients. Yet employees, managers and executives understand the ultimate goal: delivering lifesaving or life-improving therapies to those in need.
A major milestone in achieving this goal is submitting a Marketing Authorisation Application (MAA) to the regulatory authority in the country where product approval is sought. Make no mistake, this is a monumental task within the regulatory track of development. The specialised expertise of a regulatory project manager (RPM) is indispensable is developing this critical document.
Scope and scale of global regulatory activity
An MAA (or NDA/BLA/NDS) represents 10-15 years of research and development and carries a cumulative price tag often ranging between $800 million to $2.6 billion. The stakes at MAA submission are incredibly high, both in terms of investment and in the hope of delivering real solutions to patients.
In 2023 alone, the European Medicines Agency (EMA) recommended 77 medicines for marketing authorisation, 39 of which contained new active substances never before authorised in the EU. Meanwhile, the U.S. Food and Drug Administration (FDA) received 156 new applications, including 123 New Drug Applications (NDAs) and 33 Biologics License Applications (BLAs). That same year, the FDA’s Center for Drug Evaluation and Research (CDER) approved 53 novel therapeutic drugs, representing significant innovation and regulatory throughput.
Managing MAA preparation
The adage “it takes a village” is particularly apt in the context of MAA preparation. A wide range of functions ¾ including clinical, nonclinical, CMC, safety, regulatory writers, quality and publishing ¾ are involved at various stages, each focused on their specialisation and each essential to the completion of the submission. A regulatory project manager maintains a comprehensive view of the entire submission, streamlining inputs for a cohesive effort and managing the collaborative process. They facilitate discussions among subject matter experts (SMEs), organise breakout groups for complex sections and remain vigilant for risks that could impact submission readiness.
One foundational concept in project management is the triple constraint of cost, time and scope. A skilled RPM actively monitors all three to help ensure the submission stays on budget, the timeline remains on track and the content meets regulatory expectations. From verifying that all required data and eCTD modules are included, to managing timelines and dependencies, the RPM keeps the process moving efficiently.
Mapping contingency and concurrence
An RPM keeps the submission timeline front and centre. They map the critical milestones to track contingent and concurrent tasks, flag slippage early, adjust plans and prevent delays from spiralling.
Frequently, a sponsor will have a strategy to submit their dossier for approval in multiple countries simultaneously or in very quick succession. This is often structured in waves, wherein countries’ submissions are grouped together. For example, Wave 1 may be comprised of two or three countries with similar requirements, Wave 2 may include four countries, etc. This means the multiple large submissions may be running in parallel. In these cases, the role of the RPM is especially critical to maintain quality across multiple filings and identify ways to leverage efficiencies.
The RPM brings deep familiarity with the eCTD format established by the International Council for Harmonisation (ICH), ensuring the application is structured correctly within this tightly defined system. They use specialised software tools to create complex, interdependent timelines that reflect how dozens of documents fit together.
Tools of the trade: How RPMs effectively manage MAA submissions
An MAA comprises thousands of pages of documentation, from nonclinical and clinical data to intricate details on manufacturing and quality control. Each of these components may have different authors and deadlines. RPMs leverage tools to provide seamless execution, project management and end-to-end regulatory submission delivery.
Risk log: A risk log helps the team anticipate, evaluate and mitigate issues before they arise, and helps RPMs track how delays in one area can have downstream effects across the submission.
Key messages document: The best practice for ensuring consistency within the MAA is to generate a Key Messages Document (sometimes called a storyboard). This internal guide outlines the overarching themes, core messages and preferred language for describing the product and studies, ensuring clarity and alignment across the entire submission.
Reviewers’ matrix: To ensure all the required SMEs are included in document reviews, the RPM will create a Reviewers’ Matrix. This tool lays out the names and functions of all subject matter experts, along with all the documents requiring cross-functional input and review. There may be different reviewers based on what draft is in circulation, so the matrix displays which team members are reviewing which documents in a single tracker. It also indicates which SMEs will officially approve the final version of the document.
Content or Document plan: When dozens of authors are involved, document version control becomes high-risk. The RPM ensures version integrity, avoids rework and maintains a single source of submission-ready content via the use of a Content or Document Plan. This tool helps to track the status of each individual component of the MAA/NDA/BLA and also serves as a historical record of the documents comprising the submission.
Accelerating MAA development
Typically, the project of MAA preparation begins 18-24 months before the target submission date and continues until regulatory approval is secured. This includes the health authority’s review period, during which the team must be prepared to quickly respond to queries.
A best practice to keep in mind; bring an RPM in early, at least 18 months prior to the target submission date for the MAA/BLA/NDA. Although the pivotal clinical study or studies may not have concluded yet, there are projected milestone dates the RPM can use to map out different timeline scenarios. Planning ahead will allow functions to secure resourcing ahead of time. Inclusion of the RPM months ahead of the MAA/BLA/NDA kick off meeting ensures that they will have full context and understand the requirements of the submission holistically.
Ensuring high-quality regulatory submissions
RPMs ensure that quality checkpoints are enforced throughout the development process, with key quality reviews for technical, functional and editorial elements all scheduled and completed before submission. The RPM also helps anticipate Health Authority questions by working with SMEs to identify areas that may need reinforcement or clarification. They often drive planning for the Q&A response process before questions even arrive.
Driving MAA success
The MAA submission process can be long and intense. An RPM helps streamline this complicated process and oversees a cross-functional, often global team of experts to harmonise the non-clinical, clinical and CMC aspects for a comprehensive submission.
RPMs create structure, celebrate milestones, reduce chaos and maintain team momentum—especially when fatigue sets in near the finish line—to ultimately deliver timely, comprehensive, high quality MAA submissions. Achieving marketing authorisation brings the sponsor one step closer to delivering safe, efficacious treatments to patients.
Connect with us to learn how ICON’s regulatory project managers can help deliver cohesive, comprehensive MAAs to help you reach marketing authorisation sooner.