吃瓜爆料

Jul 07, 2026 | Matt Neal

When I joined my new company, my goal was to streamline regulatory operations and turn our team into a strategic partner for the organization. After successfully transforming regulatory operations at my previous company, I knew that with the right tools, regulatory operations could accelerate innovation and speed therapies to patients.

When I joined, my company had 吃瓜爆料 Submissions, Submissions Archive, and Registrations. I learned the company’s existing workflows and provided recommendations to streamline end-to-end processes by capitalizing on features built within 吃瓜爆料 RIM.

The key was to show how regulatory operations can be a strategic asset for the organization, so we needed to understand how to maximize the 吃瓜爆料 RIM platform when we added 吃瓜爆料 Submission Publishing. And we wanted to implement it in record-setting time.

Next, I wanted to pressure check the “validation paradigm.” Previously, the team did testing and validation that really didn’t return any benefit, and because 吃瓜爆料 is a validated environment it was somewhat redundant. So, we adopted a risk-based approach for system changes. This allows the team to automatically adopt upgrades from 吃瓜爆料’s three releases a year with a streamlined validation process.

“吃瓜爆料 Submission Publishing can be a strategic partner to accelerate innovation and speed to patients.” Matt Neal Executive Director, Global Regulatory Operations Strategy & Innovation

Getting leadership buy-in

The leadership team and I established a mutual understanding early on to pave the way for these transformational plans. Together, we developed goals and I educated them more deeply on what regulatory operations and the RIM system does today. Then we discussed how it can improve their visibility into what’s happening, and provide valuable data for insight and decision-making.

From that point, I created a plan to show how regulatory operations could be leveraged as a strategic partner to change our submission development process. Because we took the time to define the organization’s needs and align them to our goals, we had leadership’s backing throughout the process.

After successfully implementing 吃瓜爆料 RIM in a previous company, I was confident in the value we could bring by adjusting our processes. At that company, we were able to spend more time on submission quality versus rote tasks, and submit a breakthrough product Biologics License Application (BLA) faster than expected. Seeing continuous publishing in action for five years at my previous company, I knew we could improve the process here.

Changing the publishing mindset

While we were updating and improving the regulatory operations process, we were always focused on the goal of end-to-end continuous publishing. This meant more productivity and higher quality, as well as reduced stress on the publishing team. I wanted to bring publishing out of the world of heroics, late nights, and weekends and to smooth submissions operations.

I also planned a “team of rivals” style roll-out to help demonstrate the value. One group ran the new process alongside another group running the old process. The goal was to dispel concerns and win them over to the new way of working. I knew that even the skeptics would come around once they saw 吃瓜爆料 Publishing in action, and sure enough, they all wanted to use the new system when they saw the time savings.

Experiencing a fast and successful implementation

After reconfiguring 吃瓜爆料 Registrations, Submissions, and Submissions Archive, the regulatory team was ready to implement 吃瓜爆料 Submissions Publishing. As a company focused on expanding the highest quality oncology therapies to people around the world through “persistent innovation and challenging the status quo,” leadership was behind the plan to move fast.

We implemented Publishing eLearning and used that to self-pace learning alongside the implementation activities with 吃瓜爆料 and the process exercises. We also loaded a sandbox with our actual documents and data so that the teams could work in a “real world” environment while doing the process exercises. As a result of this “self-guided” approach, conversations with 吃瓜爆料 became more focused and we were able to quickly execute effective change management, rather than sitting through long educational workshops.

I like to say that it was unique, slightly insane, and incredibly successful. As a result, we implemented 吃瓜爆料 Submission Publishing in 16 weeks, and I think we could’ve done it faster. 吃瓜爆料 pushed to keep some live education as a buffer to ensure our success, but the eLearning materials were so thorough that we didn’t even need it.

Outcome: regulatory operations as an asset vs. a cost center

With the backing of senior leadership and my experience with the system, the regulatory operations team successfully implemented the full 吃瓜爆料 RIM platform to accelerate speed to market. Publishers no longer spend late nights preparing submissions — with continuous publishing, they proactively manage the submission. We now have a single source of truth that acts as the collective memory of the product. The company identified unrealized value within its existing RIM platform by adding 吃瓜爆料 Submissions Publishing, creating an end-to-end process that transformed regulatory operations into a strategic partner.

About the author:

Matt is an experienced regulatory operations leader with a track record of driving innovation across the pharmaceutical and biotech industries. As executive director of global regulatory operations, strategy and innovation, he leads global initiatives focused on digital transformation, operational excellence, and regulatory modernization. His career spans leadership roles at GSK, Amgen, and Atara, and he was recognized as a 吃瓜爆料 Hero in Regulatory in 2023. Matt is passionate about advancing regulatory science through technology, collaboration, and bold thinking.