My Job: Director for regulatory strategy at ISI

"My Job" is an occasional item that describes a drug development position from the first-person perspective of someone newly appointed. The intent is to provide over time a picture of positions in the industry, in hopes that the picture will be useful in career planning. -- George Miller

Image Solutions, a submissions-solutions and process-services provider in Whippany, NJ, recently announced that Lisa Jenkins was appointed director for regulatory strategy. Over a 10-year career, she has worked in product development planning, global regulatory submission strategy, dossier preparation and submission, and postapproval lifecycle management. She specializes in product labeling activities and risk management planning. Here she shares her going-in thoughts on the new job.

FierceBiotech IT: For people who aspire to a position like yours, what's the top thing they need to know but are probably unaware of? 

Jenkins: One of the keys to success in regulatory affairs is the understanding that the relationship between each drug company and any regulatory agency is unique.

I've seen situations where the FDA has worked hand-in-hand with a company to get a product to market. In this case, there was an excellent relationship between the two, fostered by clear, direct, frequent and timely communication.

I have also seen more adversarial relationships, often stemming from a company submitting sloppy work to the FDA and then failing to follow the guidance given.

I'm not suggesting that companies accept everything that regulators recommend or use a conservative developmental approach. But regulators are busy people and, like all of us, do not like to have their time wasted.

Success is based on knowing your data, preparing high-quality submissions, and communicating openly and honestly with regulators. It's difficult to change the relationship once an opinion has been formed. So it's important to get the relationship off on the right foot.

What do you love about your work? 

Building long-term partnerships with companies during product development.

I enjoy helping companies prepare for FDA meetings. Successful meetings usually translate into faster paths to approval. I also enjoy leading teams toward a common goal, like an IND, NDA or BLA submission. Focusing the efforts of all the players toward one common goal and keeping track of all the pieces and interdependencies is challenging and intellectually rewarding.

Educating those who have never "done it before" is an important part of my job and capitalizes on my skills from academia, before I joined industry. 

What keeps me most excited is knowing that my hard work has helped bring a drug or biologic through FDA approval and into the hands of patients who need it. 

What's the difference between regulatory affairs work for a solution/services provider vs. a drug company? 

It's exciting to work for a service provider because of the accelerated exposure to a breadth of scientific topics and regulatory situations. In many drug companies, regulatory leaders are "siloed" and assigned to one therapeutic area or even to a single product. In contrast, regulatory affairs consultants work on products in nearly all therapeutic areas and consequently work with nearly all FDA divisions.

Regulatory consultants also partner with companies of all sizes. Small biopharmaceutical companies have different needs and find themselves in different regulatory and business situations than larger companies.

I also have the freedom to discuss regulatory issues with the FDA outside the context of a specific application. For example, when I have a question, I can call the FDA, tell them that I am working on, and discuss the situation in a generic way without jeopardizing or implicating the company or product.

The FDA has been surprisingly amenable to this approach.

What skills does your position require?

A strong team leader is critical to success. The most effective team leaders establish responsibilities and accountabilities, are experts at problem-solving and conflict resolution, help to align team members toward goals, and know how to bring out the best in each team member. Every team is as different as the individuals on that team.

What will be different about ISI after you've been on the job for a year? 

In the next year, we plan to establish ourselves as a best-in-class strategic provider of U.S. regulatory affairs consulting, partnering with companies of all sizes on product development planning, global regulatory submission strategy, dossier preparation and submission, and postapproval lifecycle management.

We're also expanding our reach, entering partnership discussions with ex-U.S. service providers so we can provide regulatory support around the globe. 

What's the biggest change you've seen in regulatory affairs over your ten years in the industry? 

The move from paper to electronic submissions. This change has impacted the format and content of submissions as well as enabled a more efficient regulatory review.

In general, large pharmaceutical companies have embraced this change readily and have implemented solutions to adapt. Smaller companies find themselves in a difficult position of deciding whether to develop their own publishing capabilities in house or to outsource those activities. In the U.S. alone, one of the most common reasons why an application is refused for filing is due to improper or inadequate publishing.

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